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 the industry continues to see significant growth for drug products developed in cartridges, there is a trend for pharmaceutical companies to evaluate more complex drug molecules, such as biologics, ...

A leading medical device company recently teamed up with Nordson MEDICAL to redesign a crucial component for a specialized medical device. Initially, Nordson MEDICAL was tasked only with manufacturing ...

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 ...