The Medical Devices Introductory Course 2020

QMS Lifecycle

Design

QMS

Reporter •Experience

Serious Incident

PMS Art 10, Art 83- 89,Annex III

•Aware

CER

CA/PA/ FSCA

•Act

MIR •Report

RMR

P. Tiwari, 29 June 2020

RESOURCES

https://ec.europa.eu/growth/sectors/medical-devices/current-directives/guidance ● MEDDEV 2.12/1 rev.8 Guidelines on a medical devices vigilance system January 2013 ● Additional guidance on MEDDEV 2.12/1 rev.8 July 2019 ● New manufacturer incident report January 2020 ● Field safety corrective action - FSCA

Field safety notice template FSN customer reply FSN distributor/importer reply FSN Q&A Trend report Periodic summary report ● MEDDEV 2.12/2 rev.2 Post market clinical follow-up studies January 2012

The Organisation for Professionals in Regulatory Affairs