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.

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

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