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. 

Academic employees can access the recording of the webinar by logging on to our webinar material webpage with their FEIDE user.

Topics

  • 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    

Programme

09:00–09:05: Welcome
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

Kim Brügger

09:45–10:00: Questions relevant to all

 

Published Mar. 23, 2021 4:34 PM - Last modified June 7, 2021 10:17 AM