Medical consumables company Poly Medicure Ltd on Tuesday (March 11) announced that it has received Medical Device Regulation ...

A new study found that 9.1% of medical device AEs were reported to the FDA 180 days later than required over a three-year ...

More than 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) ...

For years, medtech firms around the globe (and certainly European companies) introduced their products in Europe, which requires obtaining a CE ...

A comprehensive and forward-looking regulatory framework for emerging technologies can address integration challenges, ...

Last year, the EPA issued a final rule that would limit emissions of ethylene oxide, a cancer-causing gas used to sterilize ...

The National Association of Boards of Pharmacy (NABP) plays an important role in the state licensing of prescription medical device manufacturers ...

New leadership often means new regulations for government, which can create uncertainty for cybersecurity teams that manage and protect vast networks of devices. Automation is one way to streamline ...

Discover how outsourcing regulatory submission content development improves efficiency and ensures compliance.

As of late February, there were 147 medical device recall events and 20 of them, or 13.6%, were Class I, according to a Modern Healthcare report.

The UK Government has accepted most of the recommendations of the Regulatory Horizons Council (RHC) on the regulation of AI in medical devices.

In the ever-evolving landscape of industrial safety, vigilance and adaptability are key. By leveraging the latest ...