How to keep track of all FDA rules and regulations for medical device companies

R

RobiHill

#1
Is it just me or is there anyone else having difficulties keeping track FDA rules and regulations for medical device companies. The company I work at is going to apply for FDA 510k and CE mark. We follow all the guidelines, but it is getting harder and harder to keep track of all requirements. How did you handle this issue?
 
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shimonv

Trusted Information Resource
#2
Hi Robin,
I am curious to ask what is your role and what is your product?


New rules and regulation don't come out very often, and not all of them are applicable to what you do, and there is always transition time for implementation.
If you maintain a list of applicable standards and regulation, and review it periodically, and go to trade shows, and stay in Elsmar - you should be okay. :)


Cheers,
Shimon
 
#3
In my experience, the best practice is to make a list of all requirements and sub-requirements. You can do it in a simple Excel table or even better if you use tracking requirements software.
 
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