Regulatory and medical device competence for meetings with notified bodies

Purpose and goal

Purpose and goal: This project had the purpose of hiring a medical device/regulatory affairs consultant to help prepare the company for meetings with notified bodies. The purpose with the meetings was to showcase that the Company had started working with a quality management system and a technical file. The goal was successfully achieved in that the Company had excellent meetings and has now established a good dialogue with specific notified bodies, which eventually are able to certify the product.

Expected results and effects

Successful meetings have been carried out with more than the two notified bodies that was initially planned, so the outcome was better than expected. The meetings with the notified bodies have enabled the Company to verify our regulatory pathway, as a class IIb medical device as well as our clinical strategy forward.

Planned approach and implementation

The Company has worked closely with a regulatory consultant both in helping the Company prepare for the notified body meetings as well as supporting the Company during the notified body meetings. During the time, there as been a change to the consultant working with our case, which is something that the Company immediately informed Vinnova about. The consultant has worked with the Company closely, mainly with generating documentations as part of the technical file and the quality management system. The dialogue has been efficient, cooperative and very productive.