Are you a startup 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 practical know-how regarding timing, costs and involving key stakeholders.
15:00 – Part 1: Medical device certification of software
Nila-Pia Rähle, Effectum Medical AG
- 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, lifestyle products vs. medical device, USA vs. EU, timeline and costs
16:30 – Part 2: Software development for medical apps according to IEC 62304
Rolf Kaufmann, Effectum Medical AG
- Technical documentation requirements
- Special considerations during product development
This webinar is specifically geared at startups who would like to develop a medical device software and need to get an overview of the regulatory landscape and practical advice.
Participation is free, however registration is required before May 30th, 2021.