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checklists and templates

ISO 13485:2016 vs FDA 21 CFR Part 820 Full Comparison Table 

fda-program-comparison-table

Medical device companies need to have a fundamental understanding: what is the difference between standard conformity and regulatory compliance?

Learn more in our article: ISO 13485 and FDA QSR: A Step-by-Step Guide to Complying with Medical Device QMS Requirements

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