medical device compliance

Medical electrical equipment standards are complex—and noncompliance is costly. This article breaks down the top 10 barriers manufacturers face when navigating IEC 60601 and related standards, from EMC testing and isolation diagrams to risk management and software documentation, with practical guidance to streamline certification and avoid delays.

The FDA has refreshed its list of recognized standards, adding new cybersecurity‑focused health‑informatics standards and updated materials tests used in medical devices. The latest changes signal where regulators are heading—and what manufacturers will need to show in future submissions.