Designing Safe products with IEC 60601 1

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  • Опубліковано 10 гру 2024
  • This webinar discusses how to develop medical devices, including software, that are safe, effective, reliable and bug-free and how to prove it. The standard governing the safety and essential performance of medical electrical devices is IEC 60601-1. This is arguably the most important standard in medical device development. Safety topics include electrical and mechanical hazards, usability, biocompatibility, labelling, documentation and the basic tenets of risk management. The webinar will explore the standard section by section, including its approach to compliance and how to test the device to prove compliance. This presentation will be delivered by Geoff Sizer, CEO of Genesys Electronics Design.

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