62304 Amendment Overview of Changes

In July 2015 an amendment was issued to IEC 62304. While this amendment was focused on additions for legacy software and clarifications to the use of risk in safety classification, keep in mind that a number of other smaller changes and additions were made. Some of the more significant ones include:

  1. Reduction in the exemptions for Class A software (summarized in Appendix A).
  2. New section 5.1.12 Identification and avoidance of common software defects, which requires planning to include procedures for identifying categories of defects and evidence these defects do not contribute to unacceptable risk.
  3. Sections on detailed design now require specifications detailed enough to ensure proper implementation for Class C software.

A redlined version of all changes made by the amendment can be purchased at the IEC and ANSI websites.

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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