Brodie Pedersen

Brodie Pedersen is the Chief Regulatory Officer at Borderless MedDev. He is also the Vice Chair of ICE SC62A, and the project leader of IEC 60601‑1 4th Edition.

From This Author

Standards and Compliance

The IEC 60601 Family of Standards and the 4th Edition of IEC 60601‑1

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.

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