ニュース

Med Device Online1 日

Regulatory Planning In Early Medtech Development Is The Recipe For Success

Historically, many medtech companies have engaged with the FDA in a conservative way, providing only the minimum required to ...
Med Device Online6 日

The Warning Letter Wake-Up Call In 2025: What FDA Enforcement Is Really Telling Us

FDA warning letters highlight recurring patterns, systemic gaps, and evolving priorities that medical device manufacturers ...
Med Device Online3 日

Choosing A PCD Configuration For Your Cycle

Ethylene Oxide (EO) sterilization is essential for medical device safety. Explore how Process Challenge Devices help validate ...
Med Device Online4 日

The U.K. Now Classifies Ambient Voice Technology As SaMD

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