MDR Course (Medical Device Regulation EU 2017/745)

19 - 20 June
08:45 - 16:30

Oslo Science Park
Room VIA
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.

The course is now fully booked. Please send an e-mail if you want to be informed next time this type of training is offered!

Micael Johansson will welcome you on the 19th and 20th of June 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. 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 INNOLABS/ Cross4Health granted SMEs*:   free
*1st and 2nd acceleration period

Price for Norway Health Tech Members:   7 900 NOK

Price for Non-Members:   10 000 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.

The course will be hosted at Oslo Science Park with a maximum of 15 participants and priority of seats will be given to members of companies supported within the INNOLABS project. In addition,  selected sessions will be web-streamed for INNOLABS and Cross4Health awarded SMEs.



This event is organized within the EU funded project INNOLABS.
(The INNOLABS project has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No 691556.)

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19 June

EU directives, legislation & CE Marking
The road to the CE mark through MDR
General safety and performance requirements
QMS (Quality Management Systems)/requirements with link to ISO13485:2016
PMS (Post Market Surveillance)
Clinical evaluation
Introduction of regulatory person
Requirements on distributor, importers and authorized representative
UDI, Unique Device Identification

20 June

Risk Management according to ISO 14971 & MDR
Usability according to IEC 62366-1 & MDR
Software according to IEC 62304 & MDR
Quality System according to ISO 13485 & MDR
Technical file creation
Experiences from authorities and Notified Bodies