RAPS

Make CAPA ‘cool’: FDA gives thumbs-up to framework that retools CAPA process for device makers

A new framework that rethinks the corrective and preventive action (CAPA) process by using a risk-based approach has been given the thumbs-up by the US Food and Drug Administration (FDA), with one ...
RAPS

MDCG issues guidance and templates on CAPA plans

The European Commission’s Medical Device Coordination Group (MDCG) has issued guidance and templates that notified bodies (NBs) and designating authorities (DAs) can follow when implementing ...
MD&M East

Best Practices: Managing a CAPA System

Establishing a corrective and preventive action (CAPA) system is a quality system regulation (QSR) requirement for medical device firms marketing products in the United States. Although FDA has always ...