Medical device Pharmacovigilance is the monitoring of safety profile of medical devices, from the processing and reporting of single adverse incidents through to the removal of products from the market as part of a Field Safety Corrective Action. This to ensure that patient’s and healthcare professional’s safety is monitored and action taken as soon as a safety concern with a medical device arises.
- Medical Device Pharmacovigilance – Introduction
- Classification of devices
- Quick reference on Device safety reporting requirements and timelines
- FDA – medical device safety reporting regulations
- Clinical evaluation report for medical device
- Materiovigilance Programme of India – Introduction (MvPI)
- MvPI – Reportable adverse events
- MvPI- Severity of Medical device Adverse events (MDAE) and Timeframe for reporting an event or Incident