IEC 62304 first amendment published

The first amendment to IEC 62304 amendment has been published as Edition 1.1. You can purchase just the amendment, which notates what has changed, or a consolidated redline version. It is currently available from ANSI or IEC. AAMI will publish it in the near future, although it may be expensive to purchase from AAMI.

This amendment mainly focuses on clarifying safety classification to allow consideration of factors external to software that reduce the risk of harm to potentially lower the safety class, and on stating alternative requirements for conformance for legacy software. It also clarifies the scope of the application of 62304 to software executed on a processor. This excludes various types of electronics that may have complex but hard-coded logic.

Note that outside the 62304 scope it is up to Notified Bodies to determine what is required by the medical device directives. This amendment is expected to replace edition 1 as an EU harmonized standard, but there is no timetable for this at present.

62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

Participants will gain practical advice and pragmatic experience with all types of medical software. Participants will leave with a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).

Register (click):  EventZilla Registration Site

Need info?  Email us at training@softwarecpr.com

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