This article focuses on practical strategies for medical device companies to strengthen their quality management systems and ...

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 ...

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 core message of a new guidance issued by NHS England and MHRA is clear: ambient voice technology (AVT) tools that go beyond mere transcription to include summarization are to be classified as ...

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 ...

Regulatory oversight and scrutiny of healthtech companies has emerged as a priority for the U.S. federal government. Facing triple investigations by the Federal Trade Commission (FTC), Department ...