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

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

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

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

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

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

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 ...

The EU Regulation 745/2017 on medical devices (EU MDR) lists in Annex XVI several beauty devices that the EU Commission wants to regulate as medical devices, including colored contact lenses, cosmetic ...

There is increasing pressure on manufacturers to make devices that combine safety and effectiveness with sustainability, particularly with regard to EU regulations and directives.