Article 16 of the European Union’s Medical Device Regulation and In Vitro Diagnostic Regulation specifically address the ...

In the medical device industry, FDA inspections are not a regulatory hurdle — they are a powerful tool for improving product ...

Transdermal medications can penetrate the epidermis, enter local blood arteries, and then reach the circulatory system due to their low molecular weight (<600 g/mol), addressing a variety of ...

Of all the risks associated with pharmaceuticals and medical devices, controlling contamination is one of the most important and difficult challenges. Currently, contamination risks are largely ...

The DEA has announced new rules for remote prescription of controlled substances. As telehealth adoption grows, regulatory ...

One area that medical device manufacturers often overlook in post-market surveillance (PMS) planning for EU MDR and EU IVDR compliance is the role of the supply chain.

As industries demand smaller, more complex components, micro molding has become a crucial technology. Selecting the right manufacturing partner is not just a production decision but a long-term ...

AI-enabled medical devices have become a transformative force in healthcare, offering sophisticated data-driven insights that can enhance diagnostic accuracy, personalize treatment, and optimize ...

A virtual start-up identified a significant opportunity to develop a catheter-based embolic protection device for high-risk patients undergoing transcatheter aortic valve replacement (TAVR). Lacking ...