Regulatory Documents Explained – DHF, DMR, DHR and TF



Groff noon everyone welcome to global compliance panels live webinar on the HF DMR thr and TF regulatory documents explained my name is Johnson and I'm going to be a host for today's session on behalf of the global compliance panel team I'd like to thank you for being a part of today's event today's webinar will be presented by mr. Jeff get off mister gas off is the director of quality and burn medical a leading manufacturer of endoscopy and colonoscopy devices where he all sees the operations of quality systems and this position jeff is responsible for oversight of document control systems including maintenance of regulatory documentation prior to this jeff has spent 13 years at life-taking as a director of regulatory affairs ray was responsible of a compliance of the corporate quality system jeff received his regulatory affairs certification in 1996 we are honored to have such a distinguished person such as Jeff with us to present the webinar before we begin I would like to inform you of the program outline for today's training session the webinar is for 60 minutes duration first Jeff will take you to today's webinar highlighting the areas that would be covered and he would then share with you his presentation we would like to inform all our participants once part of the teleconference have been placed on mute and will remain so until the Q&A begins towards the end of the webinar now this is done so that any kind of discontinuity is avoided and this present again speak clearly so that everyone can take maximum benefit from this webinar we also request all to hold back your questions until the Q&A window begins ten minutes of time will be allotted for the Q&A during which your questions will be answered if for any reason you do get logged out of this training session or teleconference please follow the same procedure to join in again now that we are ready to start I request Jeff to take it from here Jeff thank you so much for an introduction let me welcome everybody to this webinar for those of you who have not attended webinars before really think that the only downside the only detriment you're going to find is that I can't see you and you can't see me the way I like to address that is at the end of the webinar certainly we'll have a Q&A session but if you want to treat that as more of a discussion a give-and-take kind of thing I'm more than happy to do that whatever you know you guys the paying customers or whatever you want never work for you today's webinar as it says it's it's really all about documentation and how to make sure that you document accurately document the current status of your quality system the current status of your products and the current status of your products design and your related processes there's a lot to this when it comes to documentation and when we say documentation what I want everybody to remember is that it's okay for any of this to be electronic long gone are the days where we had books and books and binders and binders of device master records and by sister records and things like that it's okay to scan documentation and have it be virtual even outside I'm not talking about electronic signatures here I'm talking about taking pieces of paper taking for example your DHR which is the record of your assembly and scanning those pages that have been hand signed and putting them into directory and using that to illustrate your compliance I want to begin right away jump right into it with it with DD hf to design history file from a regulatory perspective the definition is just that it's a it's a compilation of records that describe the design history of your device that's a very open-ended thing but luckily there are additional requirements that we can use to determine what needs to be in our dhf a 2013 this is 21 CFR for those you who need a little clarification require that the DHS be established and maintained for each type of device so establish means that you have to have a system in place that imposes requirements on you to to put your dhf together maintained means the concept of maintenance implies a little more than implies it's a little more explicit and ongoing maintenance of this document things that has to be maintained have to be done periodically they don't just have to be set in stone and then not modified so remember your dhf is going to be a fluid document ugh F has to contain or reference records that show that your divide does I excuse me was developed now it can contain the records it can be those records you can have a DHS that is an enormous electronic file or and/or a binder of documents if you don't have that you can reference the location of these documents in a significantly smaller electronic file or a binder containing is more straightforward because when in order to prove that you've got that you've designed your product in accordance with specifications it's easier to have everything at your disposal there are many regulations and quite a few webinars as I present that deal equally with regulations because we're dealing with arguing here but to a great extent equally with good business practices things like change control where you want to meet the regulations but you want to streamline the process for the most part regulatory documents are what they are there's a list of requirements that are either imposed by regulation or by your internal processes that you have to keep so this is a very strict regulatory presentation for that reason just wanted to go inside there when you have these records that you've got to reference or contain you've got to show two things you've got to demonstrate that your design was developed according to the regulations and according to your own internal design plan so you're going to make sure that you have a requirements document most people call it an SOP that lists what needs to be in your design plan and you need to make sure that those that that document required and imposes the same requirements as the qsr are eggs it can certainly impose additional requirements I don't know why you would want to do that but there's nothing violative about that when it comes to the International regs 9001 or 1345 there's no requirement for the dhf then there is a TF a technical file requirement which overlaps the dhf to a great extent but we'll cover that later in the presentation the rationale for having a DHS is it in my mind it's very interesting that dhf is a compilation of records that show that you've got to me to just that show that you do meet the design control regulations one of the best things about the design control regulations is that each each section of the dhf has its own section of in the Q SR so you can really well leox well the requirements are deliberately not as explicit as they could be because the drafters of the regs didn't want to impose any industry specific or any model specific requirements upon us they did want to make sure that we understand the need for documenting things at the risk of talking trash about engineers engineers I'm not an engineer and my opinion engineers have you know bodies of knowledge that I can never aspire to but part of the body of knowledge they have often does not include good or I'll say compliant documentation practices so we have to make sure that we don't curtail the design process of these engineers by requiring them to do unnecessary documentation many firms have project managers or some sort of engineering technicians or associates that to a large extent follow the engineers around and write down what happens obviously the engineers are assist in that process but that's something that you want to be careful when you start to establish maintain your dhf which is going to be depending on the product of course a extremely large document that you don't impair the ability to the engineer is the design engineers that is to actually do what what their bread and butter is which is design there's no requirement as far as where you keep the dhf and how you organize it what I recommend based on my experience is that when it comes to simple designs that the designer can assemble and also then there later on maintain the entire dhf it's not going to be a very large one very integral on but when it comes to larger projects what I recommend you do is establish your document control system well you know what you already have a document control system but you utilize it for your design documents and you maintain these files in a central location one of the reasons for this would be that for a larger project a more inclusive project there's a reasonable chance that that project is very large and extensive and prend more so possibly in your company's wheelhouse than smaller projects that you may utilize design information from that larger project for further designing of other products the more that type of thing is as under the document control system the easier it is for document control to organize it and maintain it and supply it for further projects to the to the engineers where I want to begin now is to talk about the contents of reda cheff there are quite a few documents in your DHS the first thing first thing you start with and let me apologize for one thing in advance this is an hour and hour and change long webinar there are in person seminars that last several days that cover each one of these topics DHS and the DMR and things like that so while I'm giving you an abri the explanation here there's many more details that you you may want to further educate yourself on but as long as you sort of maintain this table of contents if you will and you're familiar with what needs to be for example in the approved design they put documentation well it's going to be excused without using it's going to be the design and put requirements which state what it is that the product needs to be and that documentation needs to be approved before you begin a process as you begin your process of your design process you want to make sure that you want completely understand all of the requirements that you need to maintain requirements not just customer requirements but internal requirements for example many many firms choose to have a requirement from a materials perspective that they want to try to they want to strive to use current materials or current processes manufacturing engineering may impose a use of current processes or processes but also current manufacturing equipment type of thing so all of your designing for documentation is the first section of your dhf this is followed by the design output documentation which succinctly put shows that your inputs are met and many companies use a matrix of here are inputs and this next column is – here are outputs to show that we've met them and then here the third column is evidence that we've met those outputs the evidence might be for example a design specification document or a manufacturing procedure that does specifically reference utilization of existing manufacturing equipment also the dhf has to be the design and development plans make sure when you put your plans together and these are usually Gantt charts project plans microcell projects things like that that you include in these plans each individual design task that is included including design reviews and the deliverable for each of these tasks you've got to make sure that you have both of the things each of your plans and your plan is going to evolve as the as the process itself evolves so you'll have multiple design and development plans in your dhf the FDA will expect to see multiple project plans because if they don't you haven't fully captured your entire design project and then the results of the design validation how do you know that the product you've made that the product made using these design outputs meets the design validation validation requirements that it needs to be able to fit on a particular piece of equipment if you make a consumable or if you make one part that's part of a system how you know that that part that you make does fit and can be utilized with that system as I mentioned a moment ago every design review has to be documented whether it's a major design review which is a phase of usually or an interim design review which is usually used for things like source code if there's source code that needs to be written for your design for your for your project it's not necessary to have the entire group in to review that documentation you only need to have a an interim design review but every design review has to be documented is the second bullet point there that I apologize that that's there the next the next thing that has to be in your dhf is all of the control design documents and the change control records you're at the point in your design process now where you know that this product works as made what you need to do now is make sure that all the documentation has been prepared specifications drawings procedures Quality Assurance procedures or drawings whichever you use even things like equipment maintenance if it's a new piece of equipment calibration schedules things like that all have to be maintained or referenced in your dhf when I mentioned earlier that it's usually easier or more straightforward to include food as opposed to reference certain sections in ugh F this is one where it's more the exception and the rule when it comes to referencing things like change control records you have a document control process in place at your company and that documents flow control process is one that exists outside of your design process and enables you to be able to say for example that our ecn engineering change notification number 31:48 implemented this new design of this product or this new product with this new design obviously I can have a copy of that ecn in my dhf which lists the revisions of all attached documents and therefore I therefore I've been able to reference the location of the change control records a question that you need to ask yourself when it comes to the dhf is when I make changes to my design inputs do I need to make changes to the DHS an example is often this comes across more often than not in with regard to complaint investigations you receive a complaint and when you determine that complaint is that the reported occurrence has never been accounted for it during your risk assessment during your risk management process when that happens and you begin to try to have systems in place to influence systems to address that risk to mitigate that risk that what you may see is that you need to add a design input because now you have a new requirement that the component for example be of a particular length because now my plastic opponent is so long that it's being exposed to force and snapping so now I have a new design input requirement that the length of that plastic part be shorter than a certain dimension so now I have a design input requirement do I need to change the dhf the answer is almost always yes you do need to change the dhf many firms have their design input documentation as well as their design output documentation but more so the design input docks as under Revit numeric rev control and that way we have version 1 when we first generate the design input documentation but even well before this in the process even during my design design output determinations I realize that I've omitted some design inputs I'm going to rev bump that design input documentation to Rev 2 and so on and so forth so when I get to the example or on now as far as whether we make changes to the design inputs in response to complaints I can up Rev that input documentation again to rev 3 and I may very well have to up Rev my design output documentation to its additional Rev to show that I met my new requirement going to move now to the DMR the device master records the DMR itself is how you build the product you often hear the DMO are referenced as the ritz the recipe it's a little more than just the recipe because to me a recipe is how you do something but what sometimes what's not in the recipe I don't want to debate cooking for example but the the DMR is not just a recipe it's the shopping list it's the recipe and the instructions any diagrams or drawings that are in place those are also included in the DMR the DMR contents most firms organize their DMR is their device master records by product line product family as opposed to making an individual DMR for each device you can go either way whichever you choose depending on the similarity between various products in your product line you may realize that you know there's enough different components for example that I do need to do on a DMR for each each device you may determine well you know what the only difference here is that my catheters are all of the same material but and all the same length but they're six French nine French and twelve French well that's a good example of sometime an example where you may you know decide that one DMR for product family will work if you do that you want to make sure to include all of the model numbers in your DMR then you're going to have a product description I haven't seen this everywhere that I've been just a full disclosure I've seen it in enough DMR's but I kind of like it I think it's very useful although it's more product specification related and less DMR related I kind of like it and I feel that when I present webinars I like to base a lot of my recommendations or even suggestions on my own experience so to that point I've seen product description in in DMR's not all of them but some of them and that's entirely up to you whether you want to include application and attended use in your DMR revision history the DMR itself is going to be Rev controlled and we'll talk in a few moments that the list of parts on the DMR each of those will not have a rule of Rev level on it so if my DMR for a particular widget is at Rev level a and I add a new part I'm going to up Rev my DMR to rev V I like to see DMR's that have description blocks change history design history blocks on the top or bottom of them because it really lit gives you a handle on what's changed over time it's a easier way to do it then to look at the EC own number or ECM number that's on that page go to the e Co see what's changed go to the redline document within that ECI that made that change so now I can completely understand it I'm going to have a change control block on my DMR and my other documents as well I can look at the history easily and briefly and see what's changed this is incredibly helpful for things like complaint investigations or trend based and process trend based investigations rudy moiré should have a shelf life if you have a shelf life of a sterile consumable for example if you got have a shelf life on it not so much use life recommended you slice if for an instrument just a regular tour required shelf-life quantity of units and shipment configuration many companies that sell sour consumables sell 10 for shipboard carton and then they take five cartons of ten and put them in a shipping box so you've got to make sure to account for that shipment configuration in your DMR all the documents should be listed on your DMR as I mentioned earlier just by document number and description if you like but not the recurrent revision of the part because each document itself does have a current Rev level and history of its own outside of the DMR so you can track its history that way the bill materials should have should be on there the list of parts including sub assembly so indented things like indented Bills of materials should be on there as well each of the components should be on there by part number or drawing number however you identify each of your components any drawings should be referenced or contained in the DMR some firms have inspection drawings to set of inspection procedures for example component drawings are very popular as well any manufacturing and Quality Assurance procedures some firms have one procedure that they use for both things I've seen that once or twice most firms though have 1mpa Manufacturing procedure and a QP for Quality Assurance or an IP for an inspection procedure and those documents should be referenced on the DMR as well in the list any fixtures that are used this is something that's often overlooked as inclusion in the DMR but a fixture you use is something that is used to manufacture you can't manufacture this part accurate current process with at this particular fixture and in many cases many of us many of our fixtures have drawings themselves so we identify them that way packaging procedure is another example what your packaging configuration is will have already been exact spoken to but what the packaging procedure is how you seal your pouches or how you take your large instrument and package it for shipping that's something that should be included in the DMR as well continuing the list of documents in the DMR the next one is the labeling procedure how you apply labeling or some firms have a direct print to pouch machine sterilization procedure what are your sterilization parameters or those of us who have our parameters built into let's call it sto one our sterilization procedure I would list sto one on my DMR any post sterilization inspection and testing including product release if your product comes back and you don't perform any functional testing but you perform a visual inspection of the pouch and then you do a document release to release the product those things should be explained contained on your DMR and that's going to be a procedure and then your shipping procedure many of us don't necessarily have a shipping procedures per se if you don't but obviously you do not need to include it in your DMR but if it's a procedure that you use to ship product and you restrict yourself in that manner that something that needs to be included on your DMR looking at device history records now we had the DMR and that was the recipe the shopping list the the DMR was how you make the product including all the tools and things that are used the DHR is is evidence that shows that you met that you did things according to the DMR the definition says that it contains the production history of the finished device because it is the production record for the device so you want to make sure that anything you do on that particular lot or unit is contained in your DHR any records generated during production testing for example if you do some sort of quality sure excuse me in process or finish device test if you have any rework that's done during the assembly that's got to be included here too when you perform rework make sure your we rework procedure excuse me rework procedure explicitly includes a documented hunting for confirmation that the rework did not adversely affect the device that's something that I've learned the hard way and I hope hope you all don't have to learn it the same way as well inspection it's a visual inspection as opposed to an actual test itself and acceptance from manufacturer so once these parts are issued to production which begins the manufacture process to their distribution to when they're put into stock that entire process is going to be captured in your DHR the regulation requires us to here's you establish and maintain so I have a procedure that I've got to have and I've got to update it to ensure that my records so bachelot or unit that's everything demonstrate that my devices manufactured in accordance with the DMR well that's a very interesting concept because those of us who have routers I'll call it which is the steps that are printed out by your MRP or ERP software that show the steps that your prot your your parts will go through to become a finished device many of our routers or travelers whatever you call them say things like step 10 assemble step 20 inspect step 30 send sterilizations that 40 inspects at 50 receive well that information it's up and of course people will sign or initial next to each one and they'll clued the quantities of each that made it through each step but that document omits one very important part of this actual slide that document itself in no way demonstrates that the device is manufactured in accordance with the DMR nowhere on that device did it say assemble per manufacturing procedure 100 and send the sterilization per sto one remember my example from earlier you've got to make sure that all of your travelers or whatever you call them contain sufficient reference to the DMR so that when an individual in assembly or production signs those documents they are signing that document and it's clear what it is that they've done so the DHR again shall include or refer to the location of the dates of manufacture on the quantity manufactured and the quantity released for distribution remember that you could manufacture fewer parts that are released for distribution or more parts if you perform a destructive verification test with each slot you're going to manufacture more parts than you distribute acceptance records that show that you made your device present DMR again you've got to make sure that you reference documents inspect with my inspectors initials is insufficient it's got to say inspect per QC drawn 102 31 for example also in SD HR has to be in the label and labeling that's used for each unit you have a choice here and I've seen it done probably 50/50 both ways I've seen companies that print out one extra label a sticker label on quality and they put it on a piece of paper and they have someone from production sign that that's what that's an example of what was put on their pouches for example and then have someone from quality assurance sign that they reviewed that product and this is a representation of the label that was on that product make sure that if you do sterile consumables and you have labeling for the pouch the chipboard carton and the shipping box that a sample of each of those labels appears in the DHR similarly any labels or labeling so any stickers or ifu so those of us who make instruments we have is used instructions for use for GF use whenever we call them and those are going to be included they're going to be shipped with each unit much of the time I've got to either have an example of that label or I can have an inspection record of those labels so instead of having the exact sticker or in the worst case scenario a copy of the 30 page operator's manual I can merely have an inspection record that states that part number 123 the 30 page opera use operator's manual was inspected by this person in the state it was this of and there's so many I inspected here's how many I passed or failed also the device control numbers if applicable should be in the DHR if you lot number your finish device or use serial number your finish device that's got to be contained in your DHR UDHR has to speak to a specific unit or a lot of units the contents should have the part number the work order number and quantity the operations sequence performed and the initials or the signature of the employees who perform each operation many of us have that many of us who do sell consumables will have make thousands and thousands on each shift it's okay to have multiple signatures in or near one particular blank if you subcontract any operations if you send something up for milling or machining or molding or over molding that's got to be recorded on your DHR as well any rework orders or rework information including the lac just a rationale for a lack of adverse effect of the finished device should also be included in your DHR any non-conformance –is or some sort of negative type of documentation I'll call it should also be included in thr it's it's okay to reference your non conformance report if you have n CMR number 168 it's okay just to reference that number in the D HR if the if an inspector or someone performing a investigation wants to see that document they'll have to go find that but it's okay to do that lot number serial number is appropriate I just mentioned that any relevant dates the date the worker was completed the dates of components were issued all that information anytime anyone does a Singh that's got to be dated any text and test inspection results and make sure that the test and inspection results do enable a conclusion that the product past the initials of the QA inspector it doesn't necessarily have to be a QA inspector who accepts the work order who releases is the product because they reviewed all the documentation they've determined that that documentation is acceptable that person needs to sign or initial somewhere in the DHR and the shipping record is a good thing to include in CHR because then you know where it went of all these things the shipping record is the one I see least commonly but it's a good idea to have it because then you know if you got freed you have to do some kind of recall you know exactly where the product went or if you receive complaints you know what units or serial numbers the customer or themself received from a manufacturer's perspective I like to think that the DHR enables me to evaluate my product it gives me traceability and tracking in case of emergencies such as recalls or market Corrections it enables me to train my quality data because I have a DD HR I know everything that was put into a particular component and in many cases if I lot track something I have that information as well the DHR let's also let's me evaluate do a historical evaluation of changes in the process you know the last time I made this lot number of this particular design or variances if I have deviations the deviation itself will live with the DHR so I can see what the variances are that have been implemented or put in place either proactively or reactively and it also facilitates the investigations corrective actions other important things like that from an agency perspective it shows we're doing what we say we're supposed to be doing the FDA when they look at your D hrs and they look good they will enable Dell that will enable them to conclude that your firm operates in an overall state of control which is a good phrase anytime you can hear the FDA inspector use that phrase you're doing a great job also when it comes to investigations and corrective and preventive actions the agency is going to want to see that you perform these things and conclusions that you can draw that are supported by the DHR are the most valid of all and it ensures label and control it ensure it shows the agency that I have printed out or referenced every label or labeling inside in this lot and that all those labels and labeling are in my change control process there are a couple of other DHR requirements that you want to cover kind of briefly in a 2065 traceability you're required to if you have an implant or life-sustaining device you've got a document the control number is in the DHR a 2080 when it talks about receiving and acceptance it requires us to have our acceptance activities be part of the DHR when it comes to non-conforming product a 2090 says that any time we rework and reevaluate prep product including here we go so now it's even even in the regulation including a determination of any adverse effect from the rework upon the product that's got to be in the DHR and as we've said earlier labeling label release has to be documented each of the labels and labeling has to be documented in the DHR as well and generally speaking d hrs have to be reasonably accessible to the manufacturer in the FDA and they've got to be readily available and legible the whole concept of reasonableness is just a logical thing when the FDA comes if they don't call in advance if they do call in advance you can contact your off-site storage facility if you use one and say what kind of notice we need to give you usually it's 24 to 48 hours and that's in my experience considered to be reasonably accessible when it comes to legibility there are people who let's just say get kind of creative with their signatures you want to make sure that people understand that their signatures well cool when they sign like that have to be legible for a regulatory reason you've got to be able to identify the person by initials and by signature I know a firms in which document control maintains a signature and initial book so they know that that incredibly illegible scribble is Ron Smith for example so that's an idea when it comes to legibility how long you keep the DHR either two years from the date of release or the expected life of the device whichever is longer so if you have a product that it has a three year shelf life you've got to keep it for three years if you've reprised with a one year shelf life you've got to keep it for two years technical file is the international version of the DHS and it show how it shows how you comply with the essential requirements as set forth in the medical device directive and it applies to three of the four classifications of devices classically the most restrictive devices don't require a technical file they require what's called the design dossier the only the contents are the same the only difference is that you can keep your tech files on-site for review by the notify body but your class 3 devices that have designed a phase those dossiers have to be submitted for review before you can see you mark your device the structure of the tech file begins with the introduction then the ER checklist itself continues on with the risk analysis and you can see here as we go on that while some of this has very similar if not identical information to the dhf there is a lot more to this something like a section for the risk analysis and your er checklist will that's an international concept a little more than the dit than the domestic requirements section 5 is all of your testing that went on in support of your product 6 is your clinical data 7 begins you know 7 8 begin the internal documentation so what kind of Packers in qualification did you do that's obviously very important shelf-life testing that you've done accelerated and/or real-time labeling is the if' use as well as your advertising materials have to both be included in your technical file you're gonna have to change control these as well under your EC o or document control procedure any manufacturing information is section 9 sterilization is its own section because many of us don't perform sterilization or don't contract out sterilization if you subcontract out sterilization you're going to have to include that information who your sterilizer is for example in your tech file and section 11 is the declaration of Conformity I'm going to cover each of these sections in just a little more detail to finish out this webinar the introduction has a bit of information in it it's all textual and it's not really I don't want to call it in that way it's not really technical that's going to use that terminology it begins with the products product description and then this specific specifics for use and here's the list of those how they use remember that some of this is a bit labeling related for example the indications and the contraindications and the warnings all are taken exactly from your labeling make sure that in your instructions for use you have the same exact wording as you do here in your tech file what kind of accessories go with the product many of us sell or offer accessories for example something like a cable that goes with our finished device it has a part number but they're not locked controlled and they're not sold on their own specifically for medical applications obviously you need one to use your system in many cases so in that case that accessory just needs to be listed and described listed and described here in section of the tech file any regulatory approvals that you have at this point you're going to want to list them here what your device classification is according to annex 9 of the directive and excellent walks you through it's not a flowchart per se but it's sort of a question list and it walks you through then Able's you to conclude what your device classification is and what conformity assessment route you chose as to also finish out the introduction section the ER checklist is used to show compliance to each and every aspect of the medical device directive it's a 16 or some odd page or usually it's an expression Excel spreadsheet excuse me I've given you a sample here there are many others throughout the internet for you to look at but this is one that I've used in the past and it's a large again it's a quite a fit it's not something that will take you a short amount of time to pull together when you perform your risk assessment your risk analysis make sure that you do so / iso 49 71 and that you do so for iso 4971 the newest version there's a 2012 version that that was implemented pretty recently before that I believe there was a 2008 auro 9 so it's updated quite frequently more so than things like the Q SR or the medicals right device directive or the ISO standards themselves you've got to have post market surveillance which is just a fancy way of saying complaint history and clinic clinical experience and clinical risks it's okay to have clinical experience be your complaint history that is a that is clinical feedback some firms choose to go over and above like they'll have the customer questionnaires that are sent out those are those are equally valid clinical risk because you can get from your risk asset from your from the documentation that you prepared earlier when you've tried to mitigate your design input risks so you've already prepared that domestically now you just need to included in this international document section 4 of the TF is any sort of drawings and sign of product specifications so you're going to describe the product you're going to list the components materials photographs are not required but when I submit my text files to my notify body they're very very useful I often get compliments on how easy it was to understand the product with these photos a brief description of any design control practices that you utilize it's okay to say that you're in compliance with ISO 1345 the appropriate section of that as well as a 20-point 20 I believe which is designed any verifications or validations should be as we've said throughout included or referenced here it's okay to reference them by number because these are prominent documents and in many cases there are very large prominent documents any sort of quality system certificates that your company has should be included in this section of the tech file and what is your final product release criteria those of us who sell more simple devices have really just a documentation review others it's a little more advanced so whatever your criteria is that you want to included it at this point not going to spend too much time on excuse me on section 5 other than to say that this is the testing so section 5.1 sucks about your bench testing and what it requires you to do is document a protocol which is a test plan and these are the contents that have to be within the test protocol among the most prominent that in my experience some firms forget from time to time is acceptance criteria which is what the product how the product has to perform and also calibration information sometimes we tend we sometimes we overlook the need to have the calibration information and requirements and schedules in the testing protocol and what products you're going to use and how many and what testing you're performing prior to testing many times we will perform some accelerated aging testing before we begin our validation documents and what those conditions were if you do accelerated aging once the protocol is done you're going to have a test report and that test report has to include obviously the rudd data and the statistical analysis very important is an interpretation of the data going back to talking about engineers and my experienced engineers almost always fulfill their requirements for delivering test data test results but they don't interpret things I encourage my engineers to write something to a sixth-grader in the data interpretation and conclusions you'd be surprised after they're finished laughing of course how easily understandable that that interpretation is from a interim internal audit perspective to notify body and most importantly to an FDA inspection is FDA inspectors liked it a lot when they don't have to sift through the rudd data and statistics and can get to conclusions about which they can sample the data sometimes though during our test reports we'll we'll make a mistake maybe I'm testing pull strength of an assembly but the product was Mis assembled the wrong glue is used well I'm going to include a deviation from the protocol in that I'm going to include a justification which might say something like well one part was Mis assembled so it was it's not that it felled the validation report it was that it was n/a almost so I made another product and I made it according to the procedures set forth in this put in the protocol and then here's the product just like the protocol the results document will have approval signatures you want to have people in advance approve what you're going to do and then you want them to improve approve excuse me the actual data itself the section five points who speaks to biocompatibility testing and to spend the minute here speaking to the fact that you've got to include the categorization of your device what's based on nature and duration of body contact and conclude what testing is required for the ISO standards this is the same ISO standard that is used for submissions for 510k submissions so it's very consistent throughout its application and use what testing was performed and you make sure when you get these test reports that they contain certain things many of us don't perform our own biocompatibility tests but we want to make sure that we select good firms that do so good contractors and that in the reports themselves it has the test lab accreditation a good description of the test sample that's going to come from your firm when you fill out the test request form so make sure you're as worthy as you need to be what test procedure was performed when it comes to back about by compatibility testing there are standards 1093 has multiple standards you want to make sure that the testing performed there test results reference that standard and any subsections it needs to and obviously and put bright great bright green letters or whatever color the test result five three and five four speak to microbiology and coding of devices not going to say anything about these other than to say that please note when it comes to microbiological safety and tissues animal origin there are specific stanzas that i've cited here in the presentation that you can look at to get additional information if you fall in the niche market of any of these devices clinical data is very interesting because it applies in particular to implantable devices of class three devices it doesn't apply exclusively to those it applies in particular to those so the way I've done it in the past is I base my clinical data on either a compilation of scientific literature if you're in a larger industry that is going to be scientific literature that talks about their use of ear to the purpose and use of your device but if you're not you're going to have to rely base your clinical data on the results of the clinical investigations conducted notice it doesn't say clinical trials it says clinical investigations I've seen interpretations approved by notified bodies interpreting clinical study as historical complaint data so that's something that you can use that's a good I would say if you can't find any scientific literature or actual clinical trial themselves you should feel free to go with the complaint history as your clinical results of clinical investigations that's your historical data clinical studies are required really pretty much across the board so brand-new devices modified devices that may significantly affect safety or perform an existing device that has a new indication a device that is made using a body contact material that is either a new or modified and anytime you want to extend the use life of your device you've got to perform clinical studies that support that section seven is the packaging qualification and shelf life and there are three standards that you can choose from and it's up to your firm whether you want to choose to do real-time or accelerated or both many firms will do their accelerated aging testing and when they pull their samples for that they're going to pull two times the amount of samples they'll use 1x of those for the accelerated aging and they'll use the other half so just put on the shelf and the lid sit there for two or three years depending on what their what their um shelf life is remember though that you've got to do two types of tests you have to test shelf life which is usually a sterility test but you also have to assess performance you want to be able to know you need to be able to know that your device still works after it's actually out right before it's expiration date concludes what some firms choose to do is if they have a three year shelf life they will accelerate at age to four years to assure I'm sorry accelerated and real-time age for four years to make sure that they can meet that four sterile devices so the documents you've got to have are the packaging and packaging materials including specifically whether it's tie back or paper what the film is made out of information such as that your process validation for your packaging and or sealing procedure many of us seal using a sealing machine any sort of packaging integrity test visually or a dye penetrant or a seal of pull skill strength either those are acceptable labeling integrity how do you know that your label is legible and if you use a sticky label as opposed to a direct prints pouch how do you know that it's adhered and any sort of accelerated aging studies are included in excuse me in this section as well Action 8 is all about the labeling and all that the advertising material all of your labels all of your is use you've got to make sure just as an informational thing here that the symbology you use on your labels on your I use and even on your advertising and promotional materials and your website are in compliance with en 980 or 15 to 23 it's okay to use one language on your material don't get too hooked up on the concept of national languages because it some countries do allow English as an official language others do not in those that do not you've got to make sure that you use their native language on the packaging on the devices that are sent to them advertising promotional materials should be in section 8 of the tech file as well and so should a link to or mention of your website that is certainly considered advertising material section 9 is manufacturing flowchart is a great way to start this because it sets it shows in a good snapshot the entire process when it comes to manufacturing conditions if you use either of 14-6 44 or 14-6 98 then you've got to make sure you reference them if you reference a standard here and generally speaking make sure you can demonstrate compliance to that the quality system cert for the manufacturing plant as the copy of that should go in here as well as what type of labeling control you use what your traceability requirements are any sort of in a product or inventory vironment elaborate and requirements that you have how frequently you measure them things like that if you sell a blood contact device you're going to want to include pyrogen testing in the section and you want to reference preventive monitoring of processes for example statistical process control here in the manufacturing section sterilization again very product specific you've got to comply with five fifty and eleven one thirty this section of the tech well should reference the location of the annual sterilization validation reports those each one of those is one or two if not larger gigantic binders a good looking at one now good two to three inches if not larger those are kind of large so it's okay to reference and say that in the director of quality's office that's where we maintain the annual sterilization validation reports and then someone will come here and we'll take a look at them eleven 135 requires revalidation at defined intervals and it also requires that those intervals be justified the reason I like to include that in this presentation is I guess I can't see any of you is if I were to call if I were to ask for a show of hands for those of us who are in consumables but will also do an annual sterilization revalidation I think most of our hands would go up to date I've been able to locate something in any regulation that explicitly requires the performance of annual resale relation validation having said that I don't know a firm that doesn't to it and you want to make sure that your sterilization plant is certified by a notified body at least to those two standards if not more the declination formula as opposed to me giving you even something like something as straightforward as recommended formats there are so many formats that I can't possibly explain to you if you type a declaration of Conformity either in this in this site that I'm listing here or in Google Images you will find dozens and dozens of declarations of conformity that will work for your purposes there's no set format but there is a set type of requirements so use something else that's out there so to summarize the dhf is a product line specific history of the design process from the concept phase all the race all the way through the design transfer phase all that is included in your DHS the DMR just make sure that your devices are made the way they're supposed to be made and if your DHS has a section of deliverables one one document of which was a submission of any CEO for a particular DMR that's going to be in there and that's how you can verify that remember again to include something in your DHR moving forward here that demonstrates that you make your devices in accordance with the DMR make sure you reference procedure numbers not reps procedure numbers and things like that unless the technical file is a document that does have a bit of crossover with the dhf does have some sections that are not so much crossover but its purpose is to illustrate your company's compliance and that devices compliance that is with the ers in there in the international regulations that's the end of presentation I guess we can begin to take questions now thank you so much mr. castle for the wonderful presentation and also all our participants for cooperating with us it's time now for the Q&A to begin and we request all who have questions for our presenter to click on the raise hand option which is a palm-like icon at the bottom of your participants panel you can also go ahead and paste your questions on the Q&A panel so that our present I can read out loud and then answer them if for any reason you are unable to ask your questions using either of these two means please share with me your host by chat and I shall pass it on to the present it to answer it now in the meanwhile we sincerely request you to share your feedback in the feedback form that will appear on your screen in the polling town right now the feedback form has about seven questions mostly multiple-choice in nature and wouldn't take more than two minutes of time to answer the polling will remain open to the end of the session and you can answer it even after the Q&A is done now that we have our Q&A session open participants who do have questions please click on the raise hand icon which is at the bottom of your partisans panel and I can unmute your lines and you can ask your questions directly well while we're waiting for some questions to come in I just wanted to go ahead and take you to a couple of slides of the upcoming webinars from this to cast off we have one in later this month on April 23rd and on July 24th the other one I also wanted to inform all of our participants that in case your team members call these friends might benefit from this webinar we're happy to inform you that it would be available in a recorded format and can be purchased from our website or you can call us at one eight hundred four four seven nine four zero seven okay I think we do have one question coming let me quickly throw it in Jennifer can you hear me yes again okay a best demonstrated practice for week two and look at a DMR I'm sorry if you could repeat the question once again yes concerning the device master record is there a place where we could look at a best demonstrated practice to see a picture of what this looks like an example of what what you would consider to be a great example of a DMR wow that's a good question um I think the best a handless let's let's do this why don't hate to ask it is why don't you submit that question via email to the folks at compliance panel they'll sort it to me and I'll respond with an example okay my work okay great great thank you you're welcome thank you so much I'll follow up with that question mr. Gessell okay great thanks so much well I don't see any more questions coming up I also want to inform all our participants that in case you do have any more questions that might arise please feel free to email it to us at a global compliance panel which is webinars at Global compliance panel calm or you feel free to go ahead and send it out to up to me that is Johnson that global compliance panel comm and then I can pass it on to our present to get an answer okay we do have one more question mr. gas off just going ahead and unmuting the line mr. Hansen go ahead yeah just one quick question talked about how DHS are living document and kind of skimmed over a little bit how you revise those morning of the post production States so you have feedback coming in customer complaints you update your inputs can you kind of expand on that a little bit more sure them an example of a way to do that might be twofold once your design input documentation once you've released your product you have frozen temporarily that is your input documents at whatever particular date Rev that they're that they're at perhaps that you've already modified your input documentation let's say twice during development so now is that Rev 2 when you eat once when you decide that you're going ahead and modify that you might consider folding your input documentation into your EC o process and initiating an EC or EC and what have you for that input documentation and then changing that so that your tech file has the current all the previous but as well as the current input documents so that's the way that I've seen it done that seems to take advantage of existing processes that already implemented others that clear up okay well thank you thank you so much miss gesso there's one more question quick could you go ahead yes I just had a question now with regard to the actual FDA US FDA requirements I'm assuming that you know for the seminar that the primary files mentioned here those four primary files dhf DMR EHR and technical file are those all required by the US FDA and to be titled as such now the technical file is an international ISO medical device directive related document but the other three are the DHS the DMR and the DHR are all required to be maintained perfect for the QRS our regs okay so you know we have kind of some different documentation because we produce identical devices for industrial applications we tend to have we carry dual certification for our quality systems but these we don't necessarily have each one of those a design history file a design master record and a design history record specific related to the proprietary names were spelling do you understand what I'm driving at here I finally you have you have the cot you have the contents but you don't have the titles you're meeting the requirements but their title differently to prepare some sort of policy document for your company and you know for the FDA when they come to visit of course that you know you know a change control document that says look here's what we call it but this meets the requirements of the device master record / GMP or for the QoS our requirements so just prepare I what I'll call a Tier one document that you imply that you have in your process that explains that and then you're covered okay I understand what you're saying now with regards to the requirements under each one of the the contents if you would of those files you mentioned a time some were optional and some where ideal some were recommended and and then I'm also going to assume that you know I made no to that so I'm saying that the contents are not necessarily specific US FDA requirements but that there kind of a recommended overall like can you expand on that sure I can in the best way to do that would be to take a look at in the in the regulations eight twenty point one eighty one is a device master record and eight twenty point one eighty four is the device history record if you take a look at those sections are not very large at all they will set forth the exact minimum requirements and that would be the inventory for you to assure that you're meeting just that so you said a 2181 and 184 that are advise master record into the device history record respectively yes okay all right kind of my last question on the the contents of the technical files or excuse me the contact the contents of those specifically for files we mentioned I'm assuming that those are also device specific in other words of class class of the device and for instance of the majority of devices we produce our class one non sterile non measuring throw the expense of those records a lot of that is it could be listed as not applicable that is correct okay so in those in those cases is it best to leave say the format or the place mark and say that our products are non sterile you know non measuring okay absolutely yeah you need to make sure you have placeholders as you said for each of the sections just write that applicable but also explain why it's not applicable don't just write n/a right now tap lickable this is what our device does it's clearly not a measuring device for example okay I understand okay thank you employ go alright thank you so much mr. castle ladies and gentlemen we are actually running out of time and must end our webinar session as I mentioned earlier in case you do have any further questions please feel free to share with me by chat or you can also email too Johnson a at global compliance panel calm and I shall get the answer from our presenter and sent it out to you by email at the earliest we're grateful for all of you for having taken part in this webinar and I would like to if you'd like to get in touch with us you can send us an email at webinars at global compliance panel comm we welcome your suggestions and feedbacks or ideas and how we can improve our webinars if you'd like to suggest a topic or desire a customized corporate training online or on-site we ensure that whatever your training Nessa T is it would be our priority we look forward to having you with us again sometime soon for your continued range on behalf of a present or mr. Jeff kassov and the global compliance panel team I would like to say thank you for participating in today's webinar and we wish you a pleasant day ahead thank you so much Jeff I shall follow up with you on

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