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 quality, operational efficiency, and patient safety. Shift from a reactive ...

The rapid evolution of telehealth is transforming how patients access — and physicians provide — care, a shift accelerated by policy changes adopted during the COVID-19 pandemic. The announcement in ...

The updated requirements for post-market surveillance (PMS) under the EU Medical Device Regulation (MDR), EU In Vitro Diagnostics Regulation (IVDR), and the U.K.'s forthcoming Statutory Instrument (SI ...

Loveland, CO - Nordson MEDICAL, a Nordson Company (Nasdaq: NDSN), is thrilled to unveil PharmaLok™ ZerO sanitary clamps, an innovative solution designed to replace traditional TC clamps in the ...

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 ...

Not long ago, many experts in the pharmaceutical industry were looking at the so-called patent cliff of small molecules and wondering where the next blockbuster drug or therapy innovation would come ...

Digital document control systems introduce automation into your processes. A digital solution is not only more efficient, it also makes it easier to keep up on regulatory changes and maintain ...