Requirements to place Medical Device Software and Health Software on the market

Course description

This training covers the regulations and standards applicable to Medical Device Software: mobile medical apps, web apps, connected objects, and/or standalone software for diagnosis or planning.

It also covers Health Software, not regulated as medical devices like software managing patient information.

Course outline

  • Session 1 – How to classify and quality software:
    • Introduction
    • Worldwide overview of Regulations
    • The CE Mark and the CE Directives
    • The 21 CFR and FDA guidances
    • Application to software medical devices
    • ISO and IEC standards for software medical devices
    • Paths to Clearance and CE mark
  • Session 2 – IEC 82304-1
    • Why IEC 82304-1, Scope
    • Relationships with other standards: ISO 13485, ISO 14971, IEC 62304
    • Software Requirements
    • Software Validation
    • Requirements on Instructions for Use
    • Requirements on Post-market
  • Session 3 – IEC 62304
    • Introduction
    • History of software standards in medical devices
    • Terms & definitions
    • General Requirements
    • Software Development Process
  • Session 4 – IEC 62304 (continued)
    • Software Development Process (continued)
    • Software Risk Management
    • Software Maintenance

Learning objectives

During this training, you will learn:

  • how to qualify and classify standalone software
  • what regulations are applicable to your software: CE marking, FDA
  • how to apply standards related to software : IEC 82304-1, and IEC 62304
  • how to coordinate ISO 13485 and ISO 14971 with IEC 82304-1, and IEC 62304

Who should attend

Medical Device professionals who are involved in the following areas:

  • Development of medical devices containing software, and software as stand alone medical devices
  • Risk assessment of software based product
  • QA/RA managers within companies with Medical Device Software or Health Software development
  • Purchasers involved in the purchase of Software development from subcontractors
  • Project managers handling sub-contracted Software development


  • You should have basic knowledge of how to perform scientific data base searches
  • You should have experience in writing regulatory reports /medical writing
  • You should have at least 6-12 months experience of working in the regulated industry (medical device or pharmaceutical industry).


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Date & Time
9.00-17.00 CET
IndustryMedical Device

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In-House Training

This course is available as an In-House Training course. Let us know if you wish to customize a course or if you are a large group with the same requirements.

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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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