University · Biomedical Engineering · Medical Device Design

Post-Market Surveillance and Vigilance Reporting

4 Abschnitte

EU MDR 2017/745 PMCF and PMS plan/report requirements, vigilance reporting timelines, MAUDE and FDA MDR databases, complaint handling, and CAPA processes for post-market medical device management.

Inhaltsübersicht

  • EU MDR Post-Market Surveillance: Plan, Report, and Clinical Follow-Up
  • Vigilance Reporting: Timelines, Classifications, and Field Safety Corrective Actions
  • Complaint Handling Systems and Regulatory Requirements
  • CAPA: Corrective and Preventive Action in the Medical Device Quality System
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