We are a contract manufacturer (of circuit boards) and our customers are responsible for the design and the final prodcut. Will the FDA be interested in us?

I've been doing medical device development for about 5 years now and been QA manager for a start-up for about a year and I'm still confused, so don't feel bad!

13485 is the basis for FDA QSR, but the organization and numbering is different. As long as you show how you address the QSR subjects in your 13485 system, you are OK. This is usually done with a cross-reference table in the Quality Manual.

Certification in and of itself historically has not been accepted as evidence of compliance with FDA, but they have begun an effort to accept third party certifications as evidence of compliance, so this could have changed since I last review the regs. I'm not sure what the status is of this initiative, but you should be able to find the info on the CDRH home page.

http://www.fda.gov/cdrh/index.html

Certification of your QS is optional as far as the FDA is concerned. The FDA does not require certification, only compliance, with the QSR. They will, however, inspect your facility at some point, so that in effect is a "certification" if you pass.

Assuming that you are manufacturing only, not designing or distributing the product, the onus is on your customer to ensure that you are in compliance; they will have to audit you at some point, the detail differs by the level of certification and compliance that you choose to achieve. This basically means that you don't need to be certified at all! Not exactly the route that I would recommend, however. You will eventually need to be in compliance with FDA Good Manufacturing Practices (GMP) which is nothing more than QS applied to the manufacturing processes.

This will obviously require a decision by you and your customers whether they want you to be certified to ISO 13485, which would take the burden off of them and decrease their costs. The other consideration is the added value to you of certification. You will be able to use that as a selling point to potential future customers.

For any medical device, the QS is only one part of the equation. There are other requirements of the FDA and in Europe (MEdical Device Directive) in addition to the QS such as labeling, packaging, sterilization, post-market surveillance, incident reporting, etc.

I hope that helps with some of your concerns and doesn't open Pandora's box, but it probably will.

45fan, thanks for the information.

If I understand you right, the FDA won't really be interested in us. As I stated, we are a contract manufacturer (of circuit boards) and our customers are responsible for the design and the final prodcut.

I'm pretty sure we will look at getting 13485 certified just to make everyone happy, plus it has been discussed as a marketing tool already.

Thanks again for the information. You actually satisfied my confusion (at least for this). I was mainly concerned with how much involvement we would have with the FDA considering our 'role' in all of this.

Richard,

As a contract manufacturer of printed circuit boards, you are not required to register with the FDA. You are a sub contractor of the medical device manufacturer who is registered with the FDA and subject to the FDA Quality System Regulation. The medical decive manufacturer will decide the level of control of your operation that is required. This could include requiring you to have a formal quality system, conduct site audits, first article inspections, source inspections etc.

Regarding ISO 13485, I do not think that is something you should be considering. ISO 13485 "specifies in conjunction with ISO 9001, the quality system requirements for the design/development, production and when relevent, installation and servicing of medical devices." This statement was taken from the scope of the ISO 13485 document.

My opinion is that IS0 9001 would be the way to go if you are interested in certifying your Quality System.

I just found out that in the future we will be doing box builds (final product) for one of our customers (possibly more). As far as I know, the customer will still handle the marketing and distribution though. I talked to our sales and marketing director, but you know what it's like to try and get a straight answer from a salesman :vfunny:

Since we will be building the final product instead of a part of it, would we be required to register us or the product, or do we still fall under the umbrella of subcontractor? The impression I have is that we will go ahead and pursue 13485 since it won't be much more than we are doing already and it will give us a marketing edge around here. But the FDA side of things is still confusing :confused:

Richard Olson said:

If I understand you right, the FDA won't really be interested in us.

Perhaps my comments about certification being optional were misleading. Although I have never been through an FDA audit, I believe that they WILL be interested in you at some point. ESPECIALLY since you are supplying electronic assemblies.

Just to clear the air, certification
to a standard is optional for the FDA since their controlling document is the Quality System Regulation, 21 CFR 820, aka the QSR or current Good Manufacturing Practice, cGMP. It is true that the QSR is based on 13485, but it is not quite the same to say that 13485 certification will stop the FDA from checking you out. Although I would suggest reviewing their info on third party certifications to see if FDA is going to accept these soon.

Another point to consider is that if you are NOT involved in design, then you should only need to certify to ISO 13488 which is the manufacturing only cousin to ISO 13485. 13488 basically is 13485 without design controls. BUT if you are designing the circuit board layouts, and not just manufacturing boards designed by customers, you may need 13485.

Lastly, I'm not sure about Harold's point about just needing 9001. There are specific requirements in 13485 pertaining to medical device manufacturers in many of the elements. Some of the biggies are 4.5.2 Document and Data approval and issue for document retention, many process control requirements in 4.9 for cleanliness, Handling and packaging in 4.5.1 and 4.5.4 respectively, and of course 4.16 control of quality records, which requires records be maintained for batches/lots that identifies traceability. This last one is called a Device History Record, or DHR, by the FDA, and is VERY important.

Hi 45fan,

Actually I think my statement was a bit misleading. I am sure the FDA would be interested in us, but that we wouldn't be rquired to register directly with them (although I'm not sure now).

As far as 13485, I think we are going to be waiting for the new version to be finalized and pursue that since it resembles 9001:2000 and we were going to exclude the design portion. I am trying to do some research into whether the FDA will be accepting 3rd party certifications or not, as I'm sure this would make things easier. Although navigating through the FDA website is almost a nightmare :bonk:

Part of the problem is that I am still trying to find out what we will be doing. Oh well, just another fun challenge :)

Richard,

Since you will be manufacturing a finished device, you will need to register your establishment with the FDA. You will need a Quality System in place that complies with the FDA Regulations 21 CFR Part 820. The FDA regulations are very similar to ISO 13485 and ISO 9001.

The company I work for manufactures laboratory instrumentation and several clinical diagnostic devices. In 1999 we acheived ISO 9001 and in 2002 we acheived ISO 13485. ( At the present time ISO 13485 is not a standalone standard and you must have ISO 9001. ISO 13485 has undergone a revision and will be in the format of ISO 9001-2000 and will not require that you also be certified to ISO 9001) Every 3 to 4 years the FDA comes in and spends a week auditing us.

The downside to a company like yours that may only do one or two medical devices is that your quality system must comply with the FDA regulations although only the medical devices are regulated by the FDA.

I would recommend that you contact your customers quality assurance manager and they can provide you with copies of the regulation, establishment listing information etc. If you are not already registered to one of the ISO's and do not have a formal quality system in place, it will be a major undertaking to comply with the FDA regulations.

I hope I have not further confused you.

Hi Harold, thanks for the info. I had figured we might need to register after finding out we will be doing final products.

We are currently registered to 9001:2000, so it won't be a drastic change to compy with 13485 or 820. I've read through the dratf version of 13485:2003 and have already isolated the differences and what we would need to do and have done the same with 820. I don't think it will be anything extremely difficult to do.

Guess now I need to delve into the FDA registration process. Something new to confuse me now. :vfunny:

As of right now the FDA does not accept 3rd Party Certifications, it didn't stop them from visiting us! I know this is something the FDA has explored since they are way behind on the inspections they need to perform. Until 13485:2003 is released later this year, if you wanted you can always attain ISO/EN 13485/8 Certification and would not really need ISO 9001.

You would also be correct in that 13485:2003 and ISO 9001:2000 are very similiar, there are a few subtle differences (number of required procedures, no focus on continual improvement or customer satisfaction, specifies retention time for records etc..)

As far as FDA registration Richard- fill out the form and send it in, simple as that. Oh yeah and depending on what calss you fall in will determine how soon you will see them for an inspection.

Thanks for the info on registering ISO GUY. Sounds pretty simple, I think I can handle that.

Is there someplace that I can get information about the different classes and what they would cover? I'm sure I could contact the customer to find out the class, but I would like to know for general information and if anything comes up in the future. I've been able to find some general information, but nothing too detailed. Does the class change the requirements or regulations any? If we start doing class 1, would we have to change anything if a customer wanted us to do class 2?

Sorry for so many questions (which I'm sure are pretty simple). I'm just trying to anticipate some of the questions that management will ask me :p

Richard,

The FDA web address below should help you understand the FDA inspection process (QSIT) which is based on "classes" of products / companies. The emphasis driven by risk based products & companies.

http://www.fda.gov/ora/cpgm/7382_845/msw/7382_845_part2.doc

For medical devices, FDA adopted the Quality Systems Inspection Technique (QSIT) in 1997 / 1998. They did this at the same time that they modified the regulation for medical devices (QSR- Quality System Regulation) because companies were not implementing systemic improvements to their quality systems, only repairing items that the FDA inspectors found.

As others have said, the FDA really doesn't care whether or not ISO certification exists. Their inspection force is in place to audit companies for areas of non-compliance. That being said, without or without the harmonization of standards (FDA is vigilently working towards harmonization with the 2000 standard), the principles of each quality system are the same.

As far as your companies registration, FDA does not care that you are only a contracted firm. If you supply key components or assemblies for medical devices, you are required to register. Again as others have said, its painless and other then being on the radar screen, with their current back-log, you may not see them for few years.

If I can help on a more professional level, please let me know. My company does a lot of this conversion and integration activity. You can find a reference to us in the 1st forum in this section of the Coves.

Regards,
Dave Gronostajski

Richard, you may also want to check out the Global HArmonization Task Force for the latest on where the FDA is with accepting 3rd party audits.

www.ghtf.org

I've been out of the medical device field for a couple years, but found this site to be helpful in understanding future direction.

Nice lead, Rosie.

I'll say that I found the GHTF positions on the intepretation of the requirements helpful over the years. On a side point, the book "The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices" by Trautman is a great resource and offers the GHTF guidance.

Kevin

I'm in the medical device arena and just transitioned to 9k2k last week (only 2 minors). I revised our quality manual to meet ISO 9001:2000 and ISO 13485:2003 (using the DIS). I included a cross reference matrix from 21CFR820 to ISO 9001:2000 and the quality manual.

We are also registered to ISO 13485:1996. When ISO13485:2003 is published, I will upgrade at the next audit by reviewing any changes that may have been made to the DIS then tweaking the manual and procedures. The manual basically spit back the standards and referenced the procedures. 13485 like the FDA QSR requires a lot more procedures than 9k2k, while 13485 and the QSR don't address customer satisfaction.

The FDA was here in February and found 3 minors that we corrected before they left, so the system is meeting the FDA requirements as well as ISO.

If I can help, let me know.

Originally posted by DaveG
For medical devices, FDA adopted the Quality Systems Inspection Technique (QSIT) in 1997 / 1998. They did this at the same time that they modified the regulation for medical devices (QSR- Quality System Regulation) because companies were not implementing systemic improvements to their quality systems, only repairing items that the FDA inspectors found.
After reading this statement, it seems odd to me that 13485:2003, which is being developed (I assume) with FDA input, removes the ISO 9001:2000 requirements for continual improvement and instead focuses on maintenance of the system.

BTW, Richard - are you the Richard Olson I met in Portland about 6 months ago in the ISO 9001:2000 Lead Auditor training I taught? :bigwave:

*edit - sorry about misspelling your last name * :bonk:

Originally posted by Harold
Richard,

( At the present time ISO 13485 is not a standalone standard and you must have ISO 9001.



Yes, 13485 is a standalone standard at this time.

The European harmonized medical device quality system standards are EN ISO 13485:2000 and EN ISO 13488:2000. These two standards will replace current harmonized standards EN 46001 and EN 46002 (transition period until March 2004), as published in the Official Journal (OJ) of the European Community on July 31, 2002

In the U.S., the revised Quality System Regulation (21 CFR 820, Oct. 7, 1996) was based on the ISO 9001 and ISO 13485 quality system standards. US manufacturers in compliance with the FDA Quality System Regulations can assume that their quality system is close to meeting the requirements of the ISO 9001/ISO 13485 standards.

Originally posted by howste

BTW, Richard - are you the Richard Olsen I met in Portland about 6 months ago in the ISO 9001:2000 Lead Auditor training I taught? :bigwave:

Hi Steve :bigwave:


Yes I am. I noticed that you registered recently and kept meaning to say 'Howdy'. As you can see, I am starting to branch out now, just when I was getting comfortable with 9001:2000 :vfunny:

It's good to see you here. :D I didn't think I remembered you talking about medical device much during the class. From the looks of things, that must have come up more recently.

It is a relatively new thought here. We are looking at from a marketing perspective and a couple potential customers. Nobody has asked about it yet, but we want to be able to have a plan in place for when someone does ask. So I might be going to more training :)

I might know a place you could get some training... :vfunny: I'm not a 13485/FDA/medical device expert myself, but AXEON has one on staff. I think we even have some medical device things going in Portland later this year.

I almost feel like I am intruding on a conversation here. :biglaugh: If you would like information on 13485 or FDA feel free to ask any questions you want. Not saying I know all there is to know about the Medical Device Industry, but I do know some. I have given talks for the ASQ and IMDMC on 13485.

I almost feel like I am intruding on a conversation here. :biglaugh: If you would like information on 13485 or FDA feel free to ask any questions you want. Not saying I know all there is to know about the Medical Device Industry, but I do know some. I work for a Medical Device Company, I have given talks for the ASQ and IMDMC on 13485 and dealt with a few different notified bodies.

Originally posted by ISO GUY
I almost feel like I am intruding on a conversation here. If you would like information on 13485 or FDA feel free to ask any questions you want. Not saying I know all there is to know about the Medical Device Industry, but I do know some. I work for a Medical Device Company, I have given talks for the ASQ and IMDMC on 13485 and dealt with a few different notified bodies.

Feel free to intrude anytime :D

I'm sure I will be coming up with plenty of questions in the near future as I have been given the green light to spend more time on doing some more in depth and detailed research. As I get more and more confused I'll ask plenty of stupid questions .:bonk:

I have a powerpoint copy of a presentation you gave on 13485:2003 that is very informative and handy. I know that you are definately one of the better ones on here for getting information about medical devices (figure I'll give you a big head now so you'll keep answering my questions :biglaugh: )

Al,

That conference looks like something that would be nice to go to, but I doubt I'll be going to anything at least for a couple months, until we figure out what we need to do. Based on what I've seen so far I'm sure I'll be getting a lot of good information from you as well.

Originally posted by Al Rosen
I'm in the medical device arena and just transitioned to 9k2k last week (only 2 minors).

...snip...

The FDA was here in February and found 3 minors that we corrected before they left, so the system is meeting the FDA requirements as well as ISO.

If I can help, let me know.

Al, that's pretty encouraging, you must have a good system and a good relationship with the FDA. As far as the system, I was curious how long your transition took to 13485:03 and whether you just realigned your existing procedures after adding the new requirements?

I would also like to use your experience as a sort of informal bench mark. What I'd like to know is what kinds of devices you are involved with, what classifications they are, both MDD and FDA, if applicable, and whether you design, mfg, and sell internally.

Thanks.

45fan said
I was curious how long your transition took to 13485:03 and whether you just realigned your existing procedures after adding the new requirements?

It took me abut a year, although I did not really spend a lot of time on it until the last two months. I completely revised our manual around 9001:2000 & 13485:2003 DIS and referenced our existing procedures. Where there were weaknesses I wrote new procedures or revised existing ones. I created nine new procedures and revised nine others. In some cases I created a new procedure although one existed that I thought did not accurately reflect what was being done or did not meet requirements. The upgrade was to 9001:2000. 13485:2003 hasn't published yet. I hope to upgrade in 3 to 12 months, after it is published

45fan said What I'd like to know is what kinds of devices you are involved with, what classifications they are, both MDD and FDA, if applicable, and whether you design, mfg, and sell internally.

We sell, design, mfr and install sophisticated electronic devices that are FDA class 2 and MDD class IIa. They contain software as well as hardware.

If have other questions, let me know.

Does anyone have a matrix that cross references 21 cfr 820 with 13485:2003? I'm developing my own right now, but if someone has already invented this wheel, I'd rather not reinvent it. If not, I'll post mine for review and comments when it's done.

Regards,
Linda

Does anyone have a matrix that cross references 21 cfr 820 with 13485:2003? I'm developing my own right now, but if someone has already invented this wheel, I'd rather not reinvent it. If not, I'll post mine for review and comments when it's done.

Regards,
Linda
Linda:

I created the attached comparison prior to the final release of 13485:2003. It compares 820 to 9k2k, but should be close to what you want since much of 13485 requirements corresponds to the 9k2k numbering.

Linda:

I created the attached comparison prior to the final release of 13485:2003. It compares 820 to 9k2k, but should be close to what you want since much of 13485 requirements corresponds to the 9k2k numbering.
Thanks very much!

Does anyone have a matrix that cross references 21 cfr 820 with 13485:2003? I'm developing my own right now, but if someone has already invented this wheel, I'd rather not reinvent it. If not, I'll post mine for review and comments when it's done.

Regards,
Linda
Hi Linda,

Attached is a 4 way matrix that compares 9001:1994, 9001:200, 13485:2003, and cfr 820. I believe it was made based on the final draft version of 13485, so it should be pretty accurate. Hope it helps.

p.s. I know I stole it from someone here, but can't remember who :vfunny:

Richard,

Thanks for doing the leg work. I was planning to do a cross reference with the table in the Trautman text, but now that's not necessary. One question: was the table verified by anyone?

Kevin

I've checked a good portion of it, but not every single item. It wouldn't be a bad idea to double check it though.

I'll do it then. It may take a day as my schedule is...well, yucky to say the least. Perhaps today over a late lunch.

Kevin

Thank you all for your help. I don't know what I'd do without you all (probably continue to flounder around).

Mr. Ed Kimmelman, Consultant and ISO/TC 210 SC1 Chairman representing AMMI USA once shared a matrix. See attachment.

He also told me that QSR is Quality System Records and it should be FDA QS Regulation (820).

I hope Mr Ed does not mind that his matrix is shared by all.

I hope Mr Ed does not mind that his matrix is shared by all.

This document is alreday spread over the web, so I think this is not a problem at all.

Some remarks to this matrix:

The use of the DIS and FDIS in the column headings (and within the matrix) are typographical errors.
The content of the chart is from the final, approved versions of ISO 13485:2003 and ISO 9001:2000.

Ed you writes in his table, that he did not find the regulatory definitions for "active implantable medical device", "active medical device" and "advisory notice".
These definitions are taken from Article 1 of the the COUNCIL DIRECTIVE 90/385/EEC (http://europa.eu.int/eur-lex/en/consleg/pdf/1990/en_1990L0385_do_001.pdf)

The term "advisory notice" is originally defined in EN 46001 and also
referenced in the GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM (http://europa.eu.int/comm/enterprise/medical_devices/meddev/2_12-1___04-2001.pdf)

I have checked this matrix, and I agree in the most points, but a some places in the comments I think the terms "QS Reg" and "Standard" are mixed up.

p.s.: there are also some typos in the ISO 13485:2003 Standard too (eg. in the comparison Comparison-Table Annex B Section 7.5.5 should read "Preservation of PRODUCT" (not property)

Hi all,

This is my first post. I'm a few days new to this site and am very happy to have found it. I've been given the regulatory responsibility for a start-up. We'll be integrating a class II med device. All pcb's, metal enclosures etc will be produced by sub-contractors. We don't design, this was contracted. What is the best approach for me to take for 13485 compliance/certification. We'll also need FDA 510K. I'd appreciate any advice.

Lisa,

The steps that I use with most of my clients are:

1. Get a copy of ISO 13485:2003 and perform a gap analysis to determine where the gaps are.

2. Create a project plan addressing all the gaps.

3. Document the system in a manual with several procedures ensuring that all requirements are being met. Get approval from process owners.

4. Train employees and implement the system.

5. Perform an Internal audit and address any corrective actions issued.

6. Perform a management review.

7. Perform an Internal Audit of the management review and internal audit process.

8. Send documentation to the registrar.

You should also speak to several registrars to get an idea of costs and the process.

I hope this helps.

Hi all,

This is my first post. I'm a few days new to this site and am very happy to have found it. I've been given the regulatory responsibility for a start-up. We'll be integrating a class II med device. All pcb's, metal enclosures etc will be produced by sub-contractors. We don't design, this was contracted. What is the best approach for me to take for 13485 compliance/certification. We'll also need FDA 510K. I'd appreciate any advice.
Hi Lisa:

In addition to Danny's list, don't forget a cross reference to The FDA Regulations within your Quality System Manual. I believe They will do an inspection prior to issuing you 510K approval.

I have a question regarding design. My company does not design/engineer, we are using a contract engineering firm for this. We purchased the rights to a device and needed some modifications, which included complete processor change, source code and the like. My company is outsourcing most operations. We will be performing the final integration/inspection though; does this make us responsible for the design functions? Do I need to include design in my ISO 13485 manual. I have taken an exclusion to it so far, though I have not been certified or even audited yet. I'm still in the process of writing it. Another question is will the FDA accept us using a 3rd party engineering firm for design? I'm a bit stuck here, any help you could offer will be greatly appreciated!

Thanks for the information. It'll be helpful!!

I have a question regarding design. My company does not design/engineer, we are using a contract engineering firm for this. We purchased the rights to a device and needed some modifications, which included complete processor change, source code and the like. My company is outsourcing most operations. We will be performing the final integration/inspection though; does this make us responsible for the design functions? Do I need to include design in my ISO 13485 manual. I have taken an exclusion to it so far, though I have not been certified or even audited yet. I'm still in the process of writing it. Another question is will the FDA accept us using a 3rd party engineering firm for design? I'm a bit stuck here, any help you could offer will be greatly appreciated!
FWIW my take on it is that 13485 allows exclusion of design and development controls only if regulatory requirements permit exclusions (ref: 1.2 Application). I don't see where the FDA QSR permits this (Ref: 21cfr820.30, Design controls). So to take an exclusion, the FDA regulations would have to allow it.

How do you control your sub-contactor? What controls does your sub-contractor have? Is your sub-contractor experienced with med. dev's and the neccessary controls? You can control the design that way. I think then the FDA would accept that, but your sub-contractor would be subject to an FDA Inspection.

To see what's required read through the FDA regulation I referred to above, if you haven't already. I'll bet you're doing some of it and your sub-contractor is doing the rest or should be.

Thanks for the reply. I'm still a bit confused though. It doesn't help that I'm so new to regulatory affairs. Is there a guidance document that could help me better understand what controls I need for suppliers?

Thanks for the reply. I'm still a bit confused though. It doesn't help that I'm so new to regulatory affairs. Is there a guidance document that could help me better understand what controls I need for suppliers?I haven't come across one. Try searching this site:
http://www.fda.gov/cdrh/index.html

Don't confuse the design control requirements (see attached guidance) with supplier controls. If your subcontractor is experienced with medical devices they should have no problem. I still think you will have to at least address your design controls within your system even if you are just supplying the inputs (specs/requirements) and your sub-contractor is performing the other activities. If I knew more about your processes and system, I might be able to offer some ideas.

Also try this link:
http://www.fda.gov/cdrh/qsr/contnt.html

Thanks for the reply. I'm still a bit confused though. It doesn't help that I'm so new to regulatory affairs. Is there a guidance document that could help me better understand what controls I need for suppliers?


Lisa- Welcome to the Cove!! I see you are in the Rochester Area as well.

My take on if you are Design Responsible is– if the customer is paying you to design a product, product design cannot be excluded.

Your other question about how will the FDA accept you using a sub-contractor for design. Are you asking if they will allow it??

Lisa, this sounds like a good question for the Division of Small Manufacturer's Assistance (DSMA) 800-638-2041, fax: 301-443-8818 or email dsma@cdrh.fda.gov. They were a godsend for me when I was new to medical devices. And, if you get questioned later on, you have evidence that you sought and received direction from the FDA.
Rosie

Lisa,

Who is your notified body, i.e. who will be doing your certification audit? TUV? Norske Veritas? Someone else?

If you don't have a notified body, you need to get one. You will pay a hefty fee for the audit/certification. You need to work with these folks - they can answer a lot of questions for you.

Does anyone have a matrix that cross references 21 cfr 820 with 13485:2003? I'm developing my own right now, but if someone has already invented this wheel, I'd rather not reinvent it. If not, I'll post mine for review and comments when it's done.

Regards,
Linda

Here is a file I created to help with internal auditing our processes to the regs. It crossreferences 13485:2003, the MDD, AIMD, CMDCAS, QSR, and ISO 9000:2000 (the last of which we do not comply, so those sections may be crossed out). I welcome comments!

NOTE: 060209 - Attachment removed because of errors noted by author.

Just took a quick look at your checklist and all I can say is, "Well done!" I like the way you have segregated and named the sections. Makes responsibilities obvious. Thanks for sharing.

I finished my matrix awhile ago, but it's nothing compared to this! Great structure, and I like how functional it is.

Thx,
L :applause:

I finished my matrix awhile ago, but it's nothing compared to this! Great structure, and I like how functional it is.

Thx,
L :applause:
I realize this thread is from a long time ago. Do you have the cross reference matrix (QSReg, ISO 13485, MDD 93/42 EEC, AIMDD 90/385 EEC, and IVDD 98/79 EC). Thank you in advance for anything you are able to provide!:thanx:

Hi!

Is there any information about comparsion between iso 13485:2003 und FDA QSR availible.
I'm really looking forward to recieving some help, cause I'm writing on my master thesis and really need that information + help.

Thx for helping me out.

Hi!

Is there any information about comparsion between iso 13485:2003 und FDA QSR availible.
I'm really looking forward to recieving some help, cause I'm writing on my master thesis and really need that information + help.

Thx for helping me out.

Welcome to the Cove :bigwave:

refer this link - Comparison of ISO 13485, FDA and JGMP (http://elsmar.com/Forums/showthread.php?t=23868) for comparison between ISO 13485 and 21 CFR Part 820. This has additional Japanese requirements too.

Additionally, you can do a seacrh and look for many informative posts related to the subject. :)

Hi. I was a level II certified medical device investigator for the FDA for over 21 years and am now working as an independent contract international medical device consultant.

I want to comment about the types of medical device products you have to manufacture in order to comply with FDA laws and regulations.

FDA is only concerned with finished products (and certain components/accessories- see below for details).

Unless the circuit boards can function and be sold by themselves as a component/ accessory to finished medical devices (which I know they aren't, because they are a sub-assembly in-process product used by another company to manufacture finished devices), you have to register with the FDA and follow applicable FDA laws and requirements (depending upon product classification) and be periodically audited/inspected by the FDA.

However, since these products are indeed in-process products, you are under the light of the finished product manufacturer not the FDA. This firm will require you to follow their specifications and to advise them of any changes you make to the product, components, suppliers, etc. (usually spelled out under a contract) and may even periodically audit your firm. What the other firm is doing is actually practicing purchasing control operations under 21 CFR 820.50.

Here is some guidance to aid you.

FDA defines a medical device (under the FD&C Act § 201(h)) as:

An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or similar or related article, including any component, part, or accessory which is:

(1) Recognized in the Official National Formulary, or the U.S. Pharmacopoeia, or any supplement to them,

(2) Intended for use in diagnoses of disease or other conditions, or used in the cure, mitigation, treatment, or prevention of disease in man or other animal, or

(3) Intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary purpose through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

Additionally, under 21 CFR 820.3 (l), a finished medical device is any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.

Remember, if you make components/ accessories which are ready to be used for any intended health related purpose and are packaged or labeled for commercial distribution for such health-related purpose, then you are a finished device manufacturer and have to register and follow applicable FDA laws and regulations. (In this case, the circuit boards are not components/ accessories, but are in-process sub-assemblies.)

Besudes component v finished product manufacturing, it also depends on the class of the device (i.e. frequency based on risk). Manufacturers of class III and life sustaining/life supporting class II finished product medical devices get inspected by the FDA more often than those having class II devices or class I devices. Exempt class I devices hardly ever get inspected. However, when I was with FDA, I visited all types of domestic & foreign manufacturers, US importers, repackers, spec developers, contract manufacturers, with all types of medical devices- class I expmpt to class III. REMEMBER THE SCOPE OF EU AND FDA DIFFER. JUST BECAUSE ONE PASSES AN ISO AUDIT, THE SAME MAY NOT BE TRUE FOR AN FDA INSPECTION.

Mr. Ed Kimmelman, Consultant and ISO/TC 210 SC1 Chairman representing AMMI USA once shared a matrix. See attachment.

He also told me that QSR is Quality System Records and it should be FDA QS Regulation (820).

I hope Mr Ed does not mind that his matrix is shared by all.
i am unable to download this. Could you please reattach? thank u.

i am unable to download this. Could you please reattach? thank u.

I just checked the link and it's ok, I downloaded the doc without a problem. If you're at work you may wanna try downloading this at home ;)