To streamline the oversight of manufacturers’ quality systems, and encourage improved product safety on a global scale, the International Medical Device Regulators Forum (IMDRF) has developed the Medical Device Single Audit Program (MDSAP).
How to Stay Up to Date on The Ever-Changing Landscape of the Medical Electrical Device Regulatory World
This article focuses on medical electrical devices and three countries/regions of the world, the U.S., Canada and the European Union (EU). There are a lot of regulatory, quality system and standards changes happening in the medical device space in the last couple years and these will continue in the years ahead.
Time and time again the one process that nearly always presents the most challenges to medical device companies, regardless of shape and size, is Corrective Action & Preventive Action (CAPA). This article explores those challenges and provides the reader with best practices and ways to improve the CAPA process and approach.
Clients who engage us for FDA 510(k) submission consulting often ask what testing is required by the FDA to clear their device. While testing requirements are easy to determine for some devices, other devices require intensive research.
The risk management requirements of EN/IEC/ANSI/AMIEE 60601-1-2 Edition 3 (2007) and IEC 60601-1-2 Edition 4 (2014) are mostly either ignored or misunderstood by manufacturers, their EMC test labs, and medical regulatory assessors.