On-Demand Webinar: Software Compliance for PEMS in IEC 60601 3rd Edition and Beyond


Medical Devices Manufacturers are experiencing an evolution of third party standard requirements, especially in the process areas of risk management and software development.  This complimentary 45-minute on-demand webinar provides an overview of emerging requirements for software and programmable systems, specifically highlighting three common “pain points” of software certification; software of unknown provenance, risk management for software, and legacy devices.


Course Topics

  • The definition of a programmable system
  • Risk management for programmable systems; how software and programmable systems fail
  • New requirements the IEC 60601-1 Third Edition for these systems
  • The definition of Software of Unknown Provenance (SOUP)
  • Strategies for meeting current and emerging components for legacy products.


  • Understand the elements comprising a programmable system
  • Identify the changes in software requirements in the IEC 60601-1 Third Edition for these systems
  • Refinement of risk management for software
  • Understand emerging requirement for software of unknown provenance (SOUP)
  • Identify strategies for legacy products

Learning objectives will be measured by:

  • Discussion

Target Audience

  • Product safety engineers
  • Compliance engineers
  • Product designers
  • Software engineers
  • Technical marketing professionals
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Time Requirement


Web-Based 45 minutes

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