09:30 - 10:30
The regulatory field is complex and it is changing. Get first hand knowledge about the courses on The Requirement for a Person Responsible for Regulatory Compliance (PRRC). The training for PRRC will be early next year, but join us now so you learn why this is so important.
You can see the webinar HERE!
The MDR requires in Article 15 that each manufacturer of medical devices have an appointed Person Responsible for Regulatory Compliance (PRRC). This function includes the responsibility for both the regulatory conformity of medical devices and the compliance with processes defined in the quality management system. Specifically, the tasks of the PRRC includes compliance with product conformity, the preparation and updating of technical documentation and the declaration of conformity, as well as post-market surveillance of products and report of serious incidents in accordance with applicable regulations.
This webinar will introduce you to Article 15 of the MDR and set the stage for the PRRC Breakfast Webinars and PRRC seminar coming soon. Norway Health Tech in collaboration with Obelis, a consultancy and training centers specializing in medical device regulations, would like to invite you to a quick webinar to discuss the upcoming Breakfast Webinar Series (August – December) which will prepare you for the in-depth PRRC training seminar to be held in Jan/Feb 2021. Members of Norway Health Tech and Norwegian Smart Care Cluster will receive special rates on the training seminars to come.
This webinar is relevant for all members looking for MDR guidance, specifically individuals who will be named as Person Responsible for Regulatory Compliance (PRRC).
This is part of Norway Health Tech Academy, supported by Innovation Norway.Register