Academy: PRRC Workshop Beginners

Medical device —
19 - 21 January
09:00 - 17:00


The workshop no 1 of training for PRRC – Person Responsible for Regulatory Compliance

This 3-day workshop on Person Responsible for Regulatory Compliance (PRRC) is intended to provide the initial concepts to those who are looking to understand the role of the PRRC. The training is provided by leaders in the industry that will provide you with an overview of the MDR/ IVDR. More specifically, the qualifications, experience and duties of the PRRC, the economic operators and CE marking. Specific focus will be placed on Quality Management System, risk management and Notified Bodies. Don’t miss the chance to register and learn more!

At the end of this training, you will be able to have a clear view on MDR/IVDR structure and new requirements, as well as the basic processes surrounding CE marking for your devices.

In February we will provide advanced training for PRRC and in order to attend this, you must have completed the beginners training (or relevant practical experience, to be evaluated by the training instructor)

Who should attend :

  • Medical device manufacturers management
  • Staff that will be responsible for regulatory compliance
  • RA manager, RA director, QA manager, QA director
  • Professionals preparing for the MDR/IVDR


  • For Norway Health Tech members: NOK 12 000
  • For members of other clusters and incubators: NOK 13 000
  • For non-members: NOK 16 000

There are limited spaces on the training, so sign up now if you want to secure your spot (and commit to participating).

You can also sign up for information, but you will not have secured a spot. But we will know you are interested in regulatory training and send you information on regulatory training from Norway Health Tech Academy.

If you have any questions, please contact our Regulatory Advisor Kami Faust.

19th-21st January 2021 (3 days)

10:00-10:50         CE marking & MKT Surveillance Regulation 2019/110 on marketing of
products – Sandra Ferretti

10:50-11:00           Break
11:00-12:00           Economic operators (roles, liability) – Roland Gerard
12:00-13:00           Lunch
13:00-14:30           MDR overview –Janette Benaddi
14:30-14:45            Break
14:45-16:15             IVDR overview – Louise Olliver
16:15-17:00             Q&A & Panel discussions

10:00-10:50           PRRC qualifications, experience, duties – Sandra Ferretti
10:50-11:00            Break
11:00-12:00            QMS 1 – Anne Jury
12:00-13:00            Lunch
13:00-14:30            QMS 2 – Louise Olliver & Janette Benaddi OK (theoretical & practical)
(i.e., gap 13485 and MDR)

14:30-14:45            Break
14:45-16:15             Risk management – Anne Jury
16:15-17:00             Q&A & Panel discussions

10:00-10:50           EUDAMED – UDI – Sandra Ferretti
10:50-11:00            Break
11:00-12:00            Notified Bodies – Bassil Akra
12:00-13:00           Lunch
13:00-14:30           Market surveillance – Irish & BE CA
14:30-15:15            Q&A & Panel discussions




Norway Health Tech Academy is supported by Innovation Norway



See more
19 January


Bassil Akra



Roland Gerard

Regulatory expert - Obelis

Janette Benaddi

Consultant - https://www.obelis.net/


Louise Olliver

Regulatory expert - Obelis