Counterfeit Medical Devices with QMS: Strategies for Ensuring Product Authenticity and Quality in a Global Supply Chain
By Gurpriya Kaur Introduction The rise of counterfeit medical devices poses significant threats to patient…
The Role of Clinical Evaluation Reports (CER) in Medical Device QMS
Introduction The medical device industry is highly regulated, ensuring the safety and performance of devices…
Medical Device Recalls: Root Cause Analysis and Preventive Measures
By Gurpriya Kaur Introduction Medical device recalls are a critical element of ensuring patient safety…
Understanding CAPA (Corrective and Preventive Actions) in Medical Device QMS
by Gurpriya Kaur Introduction Corrective and Preventive Actions (CAPA) are critical components of any Quality…
The Importance Of Bioburden Testing
By Steve Gonzales Bioburden testing is a critical component for medical device manufacturing to ensure…
Webinar: Understanding the New IEC 60601-1 Third Edition Amendment 2
Medical electrical equipment and systems standards are continuously updated. This can make it difficult for…
Analyzing the Changes to ISO 14971:2019
By Marcelo Trevino Historically, risk management has been a complex subject, with different stakeholders assigning different…
Four Dangerous Myths about Quality that May Cost Lives
By Anne Holland Quality is often misunderstood. More specifically, the benefits of a well implemented quality…
On Target to Save Lives
By Clare Naden Some 16 billion injections are administered around the world every year1), each one bringing…
Comments Sought on Proposed Medical Device Guidance
The International Medical Device Regulators Forum (IMDRF)—a global coalition of medical device regulators working to harmonize regulatory…