Post-Market Compliance Strategy Expertise Once your medical device goes to market, it doesn’t mean you’re done with compliance. Medical device...
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FDA Inspection Observations (483s) — Current Trends and Preventing Escalation Ideally, you will have tactics and strategies in place to...
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Ready, Set, Prep for the Four Types of FDA Inspections As a medical device manufacturer, Federal Drug Administration (FDA) inspections...
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Have you ever been in an FDA inspection? Are you prepared if your medical device company is inspected by the…
Author: Amber Hilfiger, Director of Operations and Principal Quality Engineering Consultant No one wants an FDA investigator to find an…
