R
regina
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
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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