In another first for warning letters, complaint handling supplanted CAPA as the violation found most in letters. 1 Medical device manufacturers often struggle to keep up with complaint investigations ...

Annex IV (EC Declaration of Conformity – Full Quality Assurance System) of the IVDD (98/79/EC) is all about delineating specific regulatory requirement for devices falling under List A of Annex ...

An increasing number of medical devices incorporate artificial intelligence (AI) capabilities to support therapeutic and diagnostic applications. In spite of the risks connected with this innovative ...

Among the many lessons from the COVID-19 pandemic, it’s clear that the future of healthcare belongs to those who can harness science and technology—sometimes rapidly—to improve population health ...

Jennifer S. Geetter is a partner at McDermott Will & Emery and focuses her practice primarily on the development, delivery and implementation of digital health solutions, data and research, and works ...

Evolving regulations and market requirements have kept medtech companies on their toes for years. EU MDR, for example, has been a top priority and now, more companies are moving toward EU MDR ...

Infographics can propel MedTech research and campaigns and enhance the user experience. Here Fabricio Pamplona, co-founder of online infographic maker for scientists Mind the Graph, explores the power ...

As technology component pricing continues to rise, MedTech manufacturers are applying proven methods and exploring new approaches to maintain profitability and extend product lifecycles. During the ...

Steps to ensure your medical device labels are in compliance with global regulations and have the longevity to withstand your device’s intended use. EU MDR required companies to make significant ...

The continued threat of COVID-19 and prevalence of cardiac disorders are some of the key factors driving telemedicine industry expansion worldwide. Telemedicine has been aiding healthcare systems in ...

The global medical device industry is growing rapidly and poised for steady growth. According to the Facts and Factors market research report, the global medical devices market size and share revenue ...

Introduction: A Wake-Up Call from Recent History. In the world of MedTech, traditional development processes often slow down innovation. Medical device manufacturers face an environment where global ...