How to improve a Validation program and procedures to FDA (21 CFR part 820) & ISO13485

#1
Hi Experts

I am new in QE role .I've been in Manufacturing Assembly for 10yrs and Now I am changing my career to QE position.
I would like to seek QE Expertise for the new project I am assigned to Improve Validation Program and Procedure for Medical Device in compliance to FDA (21 CFR part 820) & ISO 13485.

Is there a difference between URS ( User Requirement Specific) and Manual?
Risk Assessment Program ? Any FMEA Template can be used for Design & Process as well
 
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yodon

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#4
Ok, those are 2 pretty different subjects!

On a product, a URS is generally considered the "user needs" level document which drives product validation (which may include clinical studies). A URS is typically translated into the "engineering response" of a System Requirements Spec. This can be further broken down by discipline if needed (e.g., software, mechanical, etc.). Regardless, the URS is very different from the User's Manual which gives the user instructions on how to properly operate the device. In many cases, the risk analysis work (see ISO 14971) will drive "information for safety" which is incorporated into the user's manual. The risk management program should follow 14971.

For process validation, the risk management process often includes a process FMEA which can help drive the overall process; however, process validation is typically more framed around the process capability / assurance of always meeting spec.

There are many books, publications, websites, etc. with information on either of these and obviously a comprehensive review isn't well suited for this forum. If you have specific questions or issues, though, you can post them and will usually get excellent advice / feedback.
 
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