IEC 62304 Amendment 1 Reminder

Amendment 1 of” “IEC 62304 Medical device software — Software Life cycle processes” was issued in 2015. Although the focus of the Amendment was to include a special provision for Legacy software as well as clarifications and changes to Safety Classification, a number of other substantive changes were made.including significant additional requirements for Class A software. Paid Subscribers to SoftwareCPR.com can login and download our revised checklist with changes highlighted from the website Library. As a quick PARTIAL list of the more significant changes:- Section 4.4 Legacy Software added
– Safety Classification definitions modified to be based on Risk of Harm and after consideraton of Risk Control measures external to SW
– Section 5.1.12 procedure for categorizing defects and demonstraitng they do not result in unnaceptable risk
– Section 5.2.2.j added for IT-network aspects
– Section 5.3.5 requirement to state how to ensure segregation is effective
– Section 5.4.2 and 5.4.3 design for each unit and interface exists with enough detail for implementation
– Section 5.5.2 test procedures evaluated for adequacy
– Section 5.7 All elements now required for Class A software and more detail in 5.7 on test evaluation and records
– Sections 5.8.1, 5.8.2, 5.8.7 and 5.8.8 of Software Release now required for Class A software
– Sections 6.2.1.1, 2 and 3 added “intended use” monitoring and evaluation
– Section 6.2.3 and 6.3.2 now required for Class A software
– Section 7.1.5 and 7.3.2 are deleted removing requirement to document sequences of events as part of risk management.
– Section 9.2.1 changed to require problem reports to include a statement of criticality

SoftwareCPR experts including those involved in development of IEC 62304 and its first Amendment are available to provide guidance on its implementation as well as training.

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62304, FDA, and Emerging Standards for Medical Device and HealthIT
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