Quality Blog

Tag: fda

15 Jun 2023

How to Prepare for an FDA Inspection of Your Medical Device QMS

An FDA inspection of a medical device company’s quality management system (QMS) can be a daunting experience. However, […]

05 Mar 2015

Are ISO 13485 and FDA 21 CFR Part 820 audits the same?

Our recent newsletter Feature Article highlighted ISO 13485 audits applicable to the medical device industry.  A common question […]

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