Know-how webinar on regulatory affairs: Software as a medical device
The webinar continues our series on regulatory affairs and quality requirements for development of medical devices, with a dedicated focus on software and its special challenges.
- When is software considered a medical device?
Cases with medical software as part of a medical device and cases with stand alone software which has a medical device like application e.g. software giving treatment recommendations or providing diagnoses.
- Software accreditation
- Software validation
- How to deal with 3rd party software
- Continual product improvement
- Sensitive computing
Beate Rygg Johnsen, senior adviser for innovation and industry collaboration, the Centre for Digital Life Norway
09:05–09:45: Software as a medical device
Kim Brügger, Neuro-SysMed, Centre for Clinical Treatment Research, Haukeland University Hospital
09:45–10:00: Questions relevant to all