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 II.

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 ...

Artificial intelligence (AI) has become a commonplace reality as technology advances. Healthcare is one sector that is quickly changing on a big scale. From the issuance of electronic healthcare cards ...

Between 2000 and 2016, Chinese companies invested nearly $110 billion in the United States, according to the research firm, Rhodium Group. More than 40% of the investment occurred in 2016 alone. The U ...

The Investigational New Drug (IND) application and the New Drug Application (NDA) stages are critical milestones in drug development, but they are different applications. Developers and sponsors must ...

There are estimated to be 5,300 to 5,600 medical device companies in the United States alone, each with new, cutting-edge technologies. However, as advanced as these devices must be, above all else, ...

Fabricio Pamplona, Ph.D., is the founder of Mind the Graph, an online platform that offers thousands of accurate medical illustrations that users can download. Pamplona has a background in ...

The manufacturing industry reported nearly 850,000 injuries in 2022. That number makes up 15% of all nonfatal injuries/illnesses among private sector employees. Workplace injuries can have a domino ...

In February, Hologic received FDA clearance for its Genius Digital Diagnostics System, which combines advanced imaging with AI-assisted review for cervical cancer screening. We spoke with Mike Quick, ...

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 ...

Lars Thording, Ph.D. has a background in academia, consulting and industry leadership. He has been responsible for the launch of numerous market-disrupting solutions across healthcare, insurance and ...