Regulatory Essentials in Health Tech – Session 6 Medical Device Software

This session is dedicated to medical device software, presenting the essentials of software qualification and classification from both the EU and US perspective. The most relevant standards, IEC 62304 and IEC 82304, for software life cycle requirements are presented as well.

The Regulatory Essentials in Health Tech training series consists of eleven 2,5h webinar sessions.
Read more on the complete course here.

Time: 21.9. 2021, at 10.00-12.30
Place: Zoom
Price: single session 250€ (Prices are VAT 0%)


Target Group: All developers of medical software and stakeholders interested in gaining specific knowledge on what to take into account for the efficient commercialization of medical device software. Special focus on start-up founders and staff, university innovator teams as well as young health tech professionals and new employees.

After this session, you:

  • Know the specific regulatory requirements for developing safe and efficient medical device software.

Notice: It is recommended to follow the Regulatory Essentials sessions 1-4 prior to this course. For more specific knowledge and hands-on approach to medical device software development it is recommended to follow the one-day SOFTWARE REQUIREMENTS COURSE.



    • Software Qualification and Classification
      • The EU perspective – the MDCG 2019-11 guidance document
      • Why do all software land in class IIa or higher in EU, requiring a Notified Body?
      • The US FDA perspective
      • Unregulated software in hospitals – What to take into account?
    • Software Life Cycle requirements – Stand-alone and embedded SW
      • The IEC 62304 standard
      • Software classification in IEC 62304
      • From SW architecture to development, testing and validation (incl. IEC 82304)
      • Agile methodologies and review practices
      • SW maintenance

Participation in the training can be cancelled two weeks (14 days) before the event free of charge. For cancellations made after this, we will charge 50% of the participation fee, except for cancellations made one week before the event, we will charge a 100% participation fee.

Cancellations are always made in writing to:  
The participating organization may, if it wishes, change the participant free of charge by notifying it in writing before the event to: The participation fee will be invoiced immediately after the event. The training session will be confirmed to the participant by e-mail about a week before the event.  Labquality reserves the right to cancel the training session due to a small number of participants.

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