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 ...

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Experience the next generation of biopharma innovation with PharmaLok™ ZerO sanitary clamps. Designed to simplify and streamline biopharma processes, these advanced clamps feature a universal fit and ...

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 ...

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 ...

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 ...