13485:2016 and FDA Compliant Gap Analysis Checklist
This Gap 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.
Format: MS Word
Language: English
Product Type: Digital
Provider: 13485 Store
Language: English
Product Type: Digital
Provider: 13485 Store
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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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