FDA MDR SOP + Reportability Worksheet — 21 CFR Part 803 (USA)
€69.00Process Package — Vigilance Reporting USA (FDA MDR) Complete framework for FDA Medical Device Reporting under 21 CFR Part 803. Covers MDR reportability (death/serious injury caused or contributed to, plus the unique ‘malfunction recurrence’ criterion), 30-day standard timeline vs 5-day expedited reporting, eMDR submission via the FDA Electronic Submissions Gateway, and the §803.18 records retention…