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Certified Professional for Medical Software® - Foundation Level

Categories Software-Development for Medical Products

General Information
4 Days

The seminar will conclude with an independent certification in accordance with the "Certified Professional for Medical Software®" program. You will learn the skills required for the efficient development of medical software that is compliant to standards. First, you will learn the regulatory foundations for developing medical devices, and in particular, medical software.

Based on the requirements for a medical device and the software it contains, you will learn the most important stations in the lifecycle of the software - always in the context of the relevant standard IEC 62304. Then you will deal with the subject of risk management, one of the most important legal requirements.

The aspect of usability, which is especially important in the development of medical software, will be examined thoroughly in this course. Finally, selected subjects from the field of medical information science that you should know about as an expert in medical software will be discussed. Here the focus is on compliance with the relevant standards as well as on the question regarding how the diverse process requirements can be pragmatically accomplished.

  • Regulatory landscape
    • Legal situation in Germany, Europe and USA
    • Quality management system according to ISO 13485
  • Risk management
    • Risk management according to ISO 14971
    • Risk matrix
    • Hazard analysis techniques (PHA, FTA, FMEA)
  • Software engineering
    • Structure of IEC 62304
    • Safety classes
    • SOUP
    • Software development process
    • Software maintenance process
    • Software configuration management process
    • Software problem resolution process
  • Usability
    • Usability Engineering according to IEC 62366
    • From context of use to usage requirements
    • Usability verification and validation
  • Document management
  • Medical information science
Target audience
  • Software developers, project managers
  • None
  • The price of the seminar does not include additional exam fees.
  • If the exam is passed, the certificate will be issued by the independent certifier International Software Quality Institute (iSQI).


If you have questions about our training center, feel free to call us!

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General Terms & Conditions
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Courses 2018/19
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