FDA will immediately begin recognizing the third edition of the International Electrotechnical Commission's (IEC) family of standards for medical electrical equipment safety and performance. The third edition of IEC 60601 represents a major overhaul of the existing standard, namely by requiring medical electrical equipment manufacturers to have formal risk-management processes in place. The third edition was published in 2005, but FDA reviewers needed time to adjust to the new risk-management piece, FDA's standards management director Carol Herman explained at a March 9 session of the AAMI/FDA International Conference on Medical Device Standards and Regulation in Reston, Va. Firms will have three years to switch over to the new standard. A Federal Register notice on the topic is expected soon, Herman said
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Finland has initiated a project to improve the effectiveness of the monitoring of software intended for medical use and to ensure that software placed on its market meets the requirements set for it.
The Milner Institute, the on-campus hub for start-up acceleration at Cambridge University, hosted its annual Pitch Day on July 1. Start-ups Panakeia, PathwayBio and Sentinal4D presented diagnostic technologies.
To succeed in medtech, investors must focus on patient outcomes. Gilde Healthcare says involving patients boosts product effectiveness, access and market success — making it a smart strategy in today’s strained healthcare systems.
