Historically, many medtech companies have engaged with the FDA in a conservative way, providing only the minimum required to ...

Ethylene Oxide (EO) sterilization is essential for medical device safety. Explore how Process Challenge Devices help validate ...

FDA warning letters highlight recurring patterns, systemic gaps, and evolving priorities that medical device manufacturers ...

The core message of a new guidance issued by NHS England and MHRA is clear: ambient voice technology (AVT) tools that go ...

The digital revolution that resulted in the IoT, IoMT, SaMD, and connected devices comes with the possibility of cyberattacks. The FDAs latest efforts to enhance medical device cybersecurity include a ...

This article explains why Latin Americas demographic diversity, cost profile, and accelerating digital health infrastructure ...

Early recognition and mitigation of drug and device integration difficulties are critical to the success of combination ...

New safety-certified MLCCs with up to 500 Vrms rating, compact design, and harsh-environment resilience deliver reliable high ...

The new Test-A-Pack Model F100-2700-2 Non-Porous Package Test System provides a simple, fast, and accurate method for verifying the integrity of non-porous, flexible packages.

Whats the best utility of polymeric materials employed in healthcare and medical devices? Eric George, Ph.D., of ERG Polymers LLC discusses terminology and nomenclature, polymer structure and ...

The FDAs proposed update to the Quality System Regulation that was originally released in 1996 references ISO 13485:2016 Medical devices — Quality management systems — Requirements for ...