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 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, 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.

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN), Canada, and Italy.