regulatory compliance

Compliance engineering demands constant adaptation — and training is what makes it possible. This piece examines why continuous learning is essential for keeping pace with evolving standards, emerging technologies, and global regulatory requirements, and what it means for engineers who want to stay ahead.

The FCC has closed the door on testing labs and certification bodies in countries without a Mutual Recognition Agreement with the U.S. The new rules, effective June 1, 2026, carry fresh disclosure requirements and enforcement tools that compliance teams will need to understand.

Rising product recalls and growing regulatory complexity are putting new pressure on engineering education. This article makes the case for integrating product safety compliance into university curricula — and outlines what a comprehensive program should include.

The FCC is set to vote on new rules tightening the integrity and security of electronic device testing, including restrictions on labs in countries lacking trade agreements with the U.S. and new requirements for foreign employee disclosure, enforcement procedures, and expedited review for trusted labs.

The FDA is inviting medical device developers to participate in the READI-Home Innovation Challenge, seeking proposed solutions for home-use medical technologies that reduce hospital readmissions, with selected participants receiving direct regulatory feedback to refine their designs.

The FCC has cleared its first four drone systems from the Covered List after the Department of War determined they pose no national security risk. The move opens a conditional approval pathway for UAS manufacturers seeking U.S. import and sale authorization.

The FDA has finalized guidance on premarket submission requirements for weight loss medical devices, covering non-clinical testing, clinical study design, and benefit-risk analysis. Developers of intragastric implants, aspiration therapy systems, and neuromodulators will want to review the agency's recommendations closely.

Global markets don’t run on assumptions—they run on accredited data. ISO/IEC 17025 laboratory accreditation gives manufacturers the consistency, accuracy, and credibility regulators expect. See why accreditation has become a competitive advantage across every major industry.

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 IEC 60601 family of standards is undergoing its most significant update in decades. This article explains how the 4^th Edition of IEC 60601‑1 restructures safety, performance, terminology, and collateral requirements—and what these changes mean for medical electrical equipment development, conformity assessment, and future regulatory pathways.