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 ...
Medical Device and Diagnostic Industry (MD+DI)

QMSR Compliance Challenges: Critical Implementation Gaps Manufacturers Must Fix

Three months in, most medical device manufacturers have completed their initial gap assessments — but the harder work is only ...
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 ...
Health Affairs

Reforming The Medical Device Recall Process—A Call For Accountability

The Food and Drug Administration (FDA) issues recalls for thousands of medical devices yearly due to safety issues. In January 2024, the Government Accountability Office (GAO) formally accepted a ...