Medical Device Software - IEC 62304

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01

Course description

A course focused on the medical device software life cycle under IEC 62304, covering safety classes A, B and C, integration with ISO 14971 (risk), ISO 13485 (quality), and ANVISA, FDA (including pre-market guidance) and MDR 745/2017 expectations for SaMD and SiMD.

02

Course objective

Equip professionals to structure the development, maintenance and documentation of Software as a Medical Device (SaMD) or Software in a Medical Device (SiMD), meeting applicable international life cycle and cybersecurity requirements.

03

Course programme

24h of in-depth learning
  1. 01

    IEC 62304 scope and safety classification (A, B, C)

  2. 02

    The medical software development life cycle

  3. 03

    Planning, requirements, architecture and detailed design

  4. 04

    Implementation, verification and configuration management

  5. 05

    Maintenance, problem resolution and SOUP

  6. 06

    Integration with ISO 14971 and ISO 13485

  7. 07

    ANVISA, FDA (pre-market) and MDR expectations

04

Who can attend?

  • Software engineers, system architects, Quality and Regulatory Affairs professionals, R&D managers and consultants working with SaMD, SiMD and software embedded in medical devices.