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  • White Paper

US FDA and MDSAP Inspections for Medical Device Manufacturers

This white paper outlines the guidelines on what to expect during a US FDA medical device inspection of your quality management system.

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One of the most effective ways to support a successful FDA inspection is to always be inspection-ready. Even though the FDA generally pre-announces inspections, a few days or even a few weeks are not enough time to correct fundamental compliance issues in a quality system. This is the reason why a medical device manufacturer should always be in-spection-ready, which follows the main theme that procedures have been established and successfully implemented, records are being maintained to show conformance and, when applicable, issues identified are being corrected.

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