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 ...

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 ...

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

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 ...

In the pharma/biotech and medical device industries, the audit trail is important to have for accountability, data integrity, repeatability to create an event for investigation, and regulatory ...