08:00 - 10:00
Forskningsparken
Oslo Science Park
Workshop on regulatory issues/updated regulations on Software and Apps
Please join us for a workshop where we discuss the current regulation and changes in the regulation that determines if your software or app is a medical device – or not.
8:30 Welcome – Norway Health Tech
8:40 Software & Apps – is it a medical advice or not? By Arild Hansgard from PreSafe
9:00 Medical Device Software and Apps by Micael Johansson/Medqure AB in cooperation with Therese Albinsson/MedQtech AB
- What software and apps are regulated today under MDD (92/42/EC ) and IVDD (98/79/EC)
- New MDR – Consequences for Software and Apps
- Applicable standards within Software and Apps
”This presentation is a collaboration between MEDQURE AB and MedQTech AB. MedQtech AB is a consultant business within the medical device industry, founded by Therese Albinsson. Experienced professionals with high competence support and help customers in the fields of Quality and Regulatory compliance from startups to large companies. MEDQURE is a training academy, which Micael Johansson co-founded. As an instructor he holds a number of courses in Denmark and Sweden. Therese is a senior Quality Consultant and have support several companies into ISO 13485 certificate as well as regulatory compliance for CE-marking of Medical Devices. Micael is a senior regulatory affairs consultant. He consults startups and large companies in Europe. He is currently serving on the boards of MEDEA and Apotekearsocieteten. Micael is a member of the standard committee TK62 (handles the EN60601-series) and TK66 (EN61010-series). We both believe that our close collaboration is an advantage for our customers and will result in the most effective result for our customers business to reach market access. “
9:25 COPD online calculator – A medical tool that requires approval as a medical device or not? Customer case presented by Åse S. Mjelva/Link Medical
9:45 Discussion and wrap up
You will have the opportunity to talk to the speakers after the meeting.
Venue (for now) is social zone in Medical Growth House (Forskningsparken)
See you there!
Register