62304 Amendment 1 Reminder 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 unnacceptable 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.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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