QMSR
Gap Analysis Checklist
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Gap Analysis Checklist: FDA 21 CFR 820 to QMSR & ISO 13485:2016
41 page detailed gap analysis checklist covers all requirements of the current FDA QSR, each element of ISO 13485:2016, as well as the FDA QMSR supplemental requirements.
It can be a great tool to help you identify any gaps in your current quality management system that need to be filled in order to be compliant with the QMSR.
Details:
Pages: 41
Format: MS Word
Product Type: Digital
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Digital Product
Price $59.00
Digital Product
Price $59.00
Boonsit Chungsirporn
Executive Director TPI Glove Division
When I need help from an experienced quality system professional to act as a consultant for a start-up medical device company, I’m extremely fortunate and happy that I know Brian Newbery through our working together for 12 years when we both worked for a major multinational major medical device manufacturer.
His experience and knowledge of the ISO 13485:2016 quality standard and USA FDA regulations as well as many other international regulations continues to be a major source I go to on a regular basis.
I can highly recommend Brian to anyone looking for a quality system consultant that is both practical and has the experience and knowledge to help fast track your implementation of the
ISO 13485 Quality Management System.