New to RA: FDA Regulation Checklist/Gap Analysis



Hi all,

I'm relatively new to RA but worked within IVD manufacture for nearly 10 years.

I work for a medical devices company and I've been tasked with leading a gap analysis of our quality management system against the FDA regulations (CFR 820 Part 21?), in preparation for us applying for FDA registration.

Do any of you have a good starting point for this for example a checklist? Or some sort of comparison against ISO13485?

ANY advice would be greatly appreciated at the point.. just wandering in the dark at the minute. Haha



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Hi Peter,
Have a look at the following thread:
Looking for a checklist comparing ISO 13485:2016 and 21 CFR Part 820

It should certainly get you started.
Eventually you will need to go over your ISO 13485 compliant SOPs and compare them to 21 CFR part 820 requirements.

When time comes to do the internal audits I suggest you bring in an external auditor to check your QMS for compliance with US regulation as well.

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