08:30 - 10:00
Participants of this breakfast workshop will get to follow the whole process of the development of a medical device, from concept to production. The design and development bureau Inventas AS will together with their client (Spiro Medical AS, Dr.Scient Rolf Kahrs Hansen) explain how they developed the medical device, keeping the regulatory requirements incl. ISO13485 in mind right from the start.
We will talk about the timelines and the design control process and important lessons learned from the entire process. Also, very interesting, they will also talk about the commercialization process once the product had been certified. This is an important stage of a medical device product’s life cycle that often is taken for granted, but not necessarily that easy.
While having the project as the main story, the presenters will delve more into selected regulatory affairs items highly relevant, Risk Management, Usability Engineering and Quality Management System. This workshop will help you comprehend the importance of a regulatory strategy and qualification requirements right from the start, as well as good communication and strong project management with early definition of roles and responsibilities.
Do not miss the chance to attend this webinar, provided by experts and leaders in the industry.
Per-Anders Elvertrø, Regulatory Affairs Manager at Inventas AS
Wouter Myny is senior product designer and discipline leader for product design at Inventas AS.
Place & time:
Webinar – 3.2.2021 at 08.30-10.00 in Norway
Medical device companies and regulatory personnel