Validation of software for QMS process

Key requirements in ISO 13485, MDR , and QSReg (21 CFR 820)

Learn the concepts of QMS software validation, how to assess risks related to QMS software and how to apply IQ, OQ and PQ to QMS software.

Course description

ISO 13485:2016 introduced requirement #4.1.6 on validation of software used in QMS process. Given the complexity of software design, companies and managers expect hard times when they come to apply classical validation methods to software. Software has its own rules and concepts: failure, bugs, defects and user errors. These concepts and the way to handle them have a significant influence on the validation process. Knowing how to combine ISO 13485:2016 QMS software validation with activities of software development, installation, configuration and maintenance is the key factor to your success in the software medical device industry.

Course outline

  • Session 1
    • Introduction
    • Validation process
      • Inventory
      • Selection
      • Effort of validation
      • Additional criteria for validation
  • Session 2
    • Design qualification
    • IQ, OQ, PQ
    • Special cases: Excel, data backup-restore…

Learning objectives

  • Learn the concepts of QMS software validation,
  • Learn how to assess risks related to QMS software,
  • Learn how to apply IQ, OQ and PQ to QMS software.

Who should attend

People working for medical devices or in vitro diagnosis manufacturers:

  • Quality Assurance and Regulatory Affairs Managers
  • Software Project Managers
  • Software Development, Risk Management, and Test Engineers


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Date & Time
9.00-17.00 CET
IndustryMedical Device

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In-House Training

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Your Instructor(s)

Leading specialist with long experience of training are guiding you through regulations, guidelines, interpretations, requirements and applications.

Cyrille Michaud



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