13485:2016 and FDA Compliant Gap Analysis Checklist

Choose ISO 13485:2016 FDA Gap Checklist to develop an integrated management system that is 13485 and FDA.QSR (21 CFR 820) compliant as of April 2016 (this is the reference date of the CFR).

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13485:2016 and FDA Compliant Gap Analysis Checklist Sample page

This list has been prepared for you by the 13485 Store. You will need to have a copy of the ISO 13485:2016 standard and the quality system FDA.QSR (21 CFR 820) regulations to use along with this checklist.

You will see questions on the checklist that refer to the standard where each requirement is expressed as a question. This checklist is based on the information provided in the 2016-03-01 release of the ISO 13485:2016 international standard and on the code of federal regulations of 2016-05-26. The applicable parts of the regulation that result in additions or revisions for FDA are highlighted in yellow.