medical device compliance

A power cord might look like a commodity part, but it's one of the most heavily regulated subsystems in any globally distributed device. Five-country certification rules — covering plugs, cables, connectors, and cord sets — can quietly stall shipments if engineering teams get the documentation wrong.

The FDA has finalized its guidance on human factors information required in medical device marketing submissions, outlining a risk-based framework for 510(k)s, PMAs, De Novo requests, and HDE applications. Here's what manufacturers need to know before their next premarket submission.

The FDA has launched a pilot program featuring shorter, focused one-day facility assessments for medical products, biologics, foods, and clinical research. With 46 assessments already completed, the agency says most confirmed compliance—but standard inspections aren't going away.

This whitepaper demystifies the IEC 60601 family of medical electrical safety standards, explaining general, collateral, and particular requirements and how they impact global market access. It offers practical guidance on integrating compliance, risk management, and testing strategies early to streamline regulatory approval and accelerate time to market.

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.