MDR Course / Software as a Medical Device

28 - 29 November
09:00 - 16:30

Oslo Science Park
Room Hagen 4
Gaustadalléen 21
0349 Oslo

Are you working with Medical Devices? Are you somehow exposed to the new EU regulation your company’s product needs to comply with? Then this course is of high value for you.
Let us guide you through the Medical Device Regulation EU 2017/754.

Micael Johansson will welcome you on the 28th and 29th of November 2019 to a 2-day course at the Oslo Science Park.

This course offers you a good insight on the road map to the CE mark through the MDR.  The gained knowledge will help you getting started with the classification of your device, establishing a Quality Management System and involving a Notified Body. A well explained overview of all related processes and documents will be provided. You will get the chance to apply your newly obtained knowledge working on related exercises during the second course day. The second day will focus more in depth on software as a medical device including ISO 14971, IEC 62366 and 62304.

Printed course material as well as a course certificate will be handed out.
You can find the full program at the end of this site.

Price for Members of Cross4Health / INNOLABS granted SMEs*:   free
*1st and 2nd acceleration period

Price for Norway Health Tech Members:   7 900 NOK

Price for Non-Members:   12 000 NOK

The prices include the course certificate, printed material as well as all served meals for the two days.

Our speaker is an experienced regulatory and quality consultant, chairman of the Apotekarsocietetens board (medical device section) and consults to Startups as well as large companies all over Europe. He is a member of the standard committee TK62 and TK66, handling the EN60601 and EN61010 series. Micael has held many courses in Denmark and Sweden before. This course will be empowering and hands on.


Please note:
The course will be hosted at Oslo Science Park with a maximum of 15 participants.  Therefore, we limit the number of attendees per company to 2.
Priority of seats will be given to members of companies supported within the Cross4Health project. Cross4Health companies need to register before the 18th of November to make use of the priority seats. Other companies will receive their final confirmation on the 19th of November sent out by Claudia Marx.



Feel free to contact Claudia in case you have questions or need further information.



This event is organized within the EU funded project Cross4Health.
(The Cross4Health project has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No 731391 .)



See more
28 November

Day 1

  • EU directives, legislation & CE Marking
  • MDR (MDD & AIMD) and some IVDR (IVDD)
  • Classification MDR/(MDD)
  • The road to the CE mark through MDD/MDR
  • Major changes in MDR such as:
    General safety and performance requirements
  • Technical file creation
  • Updates in QMS (Quality Management Systems)/requirements with link to ISO13485:2016
  • Updates in PMS (Post Market Surveillance)
  • Updates in classification
  • Updates with regards to clinical evaluation
  • Introduction of regulatory person
  • Requirements on distributor, importers and authorized representative
  • UDI, Unique Device Identification
29 November

Day 2 - Focus: Software as a Medical Device

Days 2 will have a depth and focus on SaMD (Software as medical device).

In depth of the newly released MDCG-2019, qualification/classification of SaMD.

  • How to qualify SaMD
  • How to classify acc to MDR/IVDR

Introduction to, with a SW touch:

  • Risk Management according to ISO 14971 & MDR
  • Usability according to IEC 62366-1 &MDR
  • Software according to IEC 62304/82304 &MDR
  • Quality System according to ISO 13485 & MDR
  • Cyber security for SaMD
  • Introduction to FDA legislation
  • Exercises


Micael Johansson

Senior Regulatory & Quality Consultant