Tag: FDA regulatory compliance

Medical Device Reporting & Complaint Handling – XPRO AMERICA

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Medical Device Reporting (MDR) under 21 CFR Part 803 requires manufacturers, importers, and device user facilities to report adverse events and product problems to the FDA. Compliance with MDR regulations…

eSTAR & eCopy Submissions for FDA Devices – XPRO AMERICA

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The FDA requires electronic submissions for medical device applications, including 510(k), De Novo, and PMA pathways. Two primary formats are used: eCopy and eSTAR (Electronic Submission Template And Resource). Correct…