$SCPR 62304 Checklist Revised for Amendment 1$

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The link provided is our revised checklist for changes in Amendment 1. To aid in understanding, all substantive changes to our checklist associated with changes in the Amendment 1 of 62304 issued in 2015 are highlighted in yellow.

This amended checklist was prepared by Mary Decareau and Alan Kusinitz and reviewed by Raffaele Caliri of SoftwareCPR.

Amendment 1 “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). Below is 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 consideration of Risk Control measures external to SW
  • Section 5.1.12 procedure for categorizing defects and demonstrating they do not result in unacceptable 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 the 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. We hope you find this training and assessment aid for useful. If you have any questions let us know by leaving a message below:

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  • Agile principles that align well with medical
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This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

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