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Medical Device Certification of Software & Software development for medical apps according to IEC 62304 (EN)

Are you a start-up developing a potential medical device software? If so, this webinar is for you. We will provide an overview of important insights on both, strategic and operational levels. You will learn about the regulatory framework, requirements and essential tools and questions you should consider during your development process. Furthermore, you will benefit from speakers practical know-how regarding timing, costs and how to early involve key stakeholders.

This webinar is specifically geared at start-ups who would like to develop a medical device software and need to get an overview of regulatory landscape and some practical advice.


Part 1: Medical Device Certification of Software

  • What is medical device software?
  • How to classify the medical device software
  • Conformity Assessment routes
  • Regulatory requirements to consider in product development
  • Strategic considerations: DIGA, life-style products vs. medical device, USA vs. EU, timeline and costs
Register for Part 1

Part 2: Software development according to IEC 62304 

  • Technical documentation requirements
  • Special considerations during product development
Register for Part 2



Regulatory Affairs Framework for software
Nila-Pia Rähle, Effectum Medical AG




Software Development Inside this Framework
Rolf Kaufmann, Effectum Medical AG



Participation is free, however registration is required before September 21, 2022.

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