The Medical Devices Introductory Course 2020

BS EN ISO 14971: Overview of structure and contents

Pre-market •

Post-market • complaints •

published standards; scientific technical data;

vigilance data

•

• field data from similar medical devices already in use, including published reported incidents; • usability tests employing typical users; • clinical evidence; • results of appropriate investigations; • expert opinion

literature reviews

•

• data from similar devices on the market • updates to standards and guidance documents • new data which affects risk assessment • customer feedback • production / QMS feedback • servicing / installation / maintenance logs

ISO 14971:2019 Clauses 5.5

The Organisation for Professionals in Regulatory Affairs

BS EN ISO 14971: Overview of structure and contents

Harm

Hazard

The Organisation for Professionals in Regulatory Affairs