ISO 13485 vs. FDA QSR (21 CFR Part 820) - Differences - Includes Spreadsheets

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Al Rosen

Staff member
Super Moderator
#42
lisa1666 said:
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.
 
L

lisa1666

#43
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?
 

Al Rosen

Staff member
Super Moderator
#44
lisa1666 said:
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:
Was: http://www.fda.gov/cdrh/index.html (Dead)

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:
Was: http://www.fda.gov/cdrh/qsr/contnt.html (Dead)
 

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A

Aaron Lupo

#45
lisa1666 said:
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??
 
R

RosieA

#46
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 [email protected]. 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
 

pbojsen

Involved In Discussions
#47
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.
 
C

compliance - 2006

#48
Matrix crossreference with text

Linda LaVine said:
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.
 
4

45fan

#49
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.
 

lindal

Involved In Discussions
#50
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:
 
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