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

A

amyjpowers

#61
Re: ISO 9001+ISO 13485+FDA QSReq.

The cross reference matrix is wonderful! Being a "newbee" to medical device standard the Cove is a great place to hang out. I was wondering, since the inception date of the matrix is 2004, should I be concerned that the federal regulation may have changed? Does the QSR ever have updates?
 
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P

pthakor

#62
Re: Differences: ISO 13485 vs. FDA QSR (820) - Includes Spreadsheets

Hi Danny. I like your plan. I am very new to Medical Device Manufacturing. I am wondering if you already have made gap analysis and presentation, is it OK with you to send me your gap analysis and presentation? It will be a great help.
Thx
Pete
 

Weiner Dog

Med Device Consultant
#63
Re: Differences: ISO 13485 vs. FDA QSR (820) - Includes Spreadsheets

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??
Good day. For additional clarification, the specification developer is the person or company who owns the class I, II, III product [510(k) or PMA depending upon the FDA classification] & has name on labeling (approves product specifications, labeling &/or packaging). In many cases, the spec developer does not have the resources, technical know-how, and/or equipment/ facilities to design and/or manufacture the product. Thus, the company finds contract design houses and/or contract manufacturers (if they also do design controls). These 21 CFR 820 operations are handled by the contract company(ies), but under purchasing controls, the spec developer is ultimately responsible for the design and/u=or manufacture of the medical device. (Note: Certain class I, but all class II and all class III FDA medical devices have to undergo design controls).

FYI- I worked for the FDA as an international level II certified medical device investigator for over 21 years...

I hope this helps.
 

Weiner Dog

Med Device Consultant
#64
Re: ISO 9001+ISO 13485+FDA QSReq.

The cross reference matrix is wonderful! Being a "newbee" to medical device standard the Cove is a great place to hang out. I was wondering, since the inception date of the matrix is 2004, should I be concerned that the federal regulation may have changed? Does the QSR ever have updates?
Yes, the QSR, as do other code of regulations, have periodic updates. These updates are typically first published as federal register announcements for comment by industry. For the most current updates, please check the following FDA website: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

One should never have to pay some consulting company big bucks for CFRs or FDA guidance documents, because they are all free on the FDA website. All that you do is have to know where to look.
 
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