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Academy: PRRC Workshop Beginners

19 - 21 januar
09:00 - 17:00

Online

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

Pricing:

  • 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.

 

 

 

Norway Health Tech Academy is supported by Innovation Norway

Påmelding

Speakers

Bassil Akra

CEO - QUNIQUE GmbH

bassil.akra@quniquegroup.com

Roland Gerard

Regulatory expert

Janette Benaddi

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

jbenaddi@outlook.com

Louise Olliver

Regulatory expert - Obelis