The 10 most common FDA Form 483 findings hitting medical device manufacturers in 2026. Updated for QMSR with actionable fixes from real inspection data.
FDA has been explicit: ISO 13485 certification does not equal QMSR compliance. The agency does not rely on third-party certificates as evidence of compliance. Here are the seven gaps FDA investigators will target first.
Regulatory Excellence for Device Manufacturers. Elite Quality & Regulatory consultancy specializing in ISO 13485, FDA compliance, and medical device manufacturing excellence.
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