Person Responsible for Regulatory Compliance (PRRC) is a new role introduced in MDR and IVDR and is required for all medical and IVD device manufacturers to have this person identified and allocated.
The PRRC has the responsibility for regulatory compliance for devices on the market, in clinical trials and clinical performance studies. This is conducted by ensuring that the technical documentation and declaration of conformity is drawn up and kept up to date, fulfilling the obligations related to post market surveillance as well as reporting and investigating vigilance issues. It is also required that the PRRC controls the conformity of devices before they are released to the market.
Learn how a PRRC could be introduced into you organization and interpret the requirements for your devices. During the course, the following topics will be covered
- Article 15
- PRRC qualifications
- External or internal PRRC
- Responsibilities and authorities
- Legal aspects
- Available guidelines
Medical device manufacturers, management and QA/RA professionals. Prior experience of MDR/IVDR and ISO 13485 is required.
Course material will be in English, verbal presentation and discussions in English.
Emma Axelsson, Senior Quality and Regulatory Consultant
Dates and location
Half-day course: SEK 3 400:-
All prices excl. local VAT.
*For group registrations, the 2nd and 3rd persons from the same company will receive a 10% discount. For 4th and additional persons, a 20% discount will be applied.
Customized training courses and seminars
We provide training courses and seminars, both as open courses / seminars and
as customer specific trainings.
Cancellations must always be communicated to Academy@qadvis.com and confirmed by us. Cancellations made more than 4 weeks before the starting date are free of charge. Cancellations made 4–2 weeks before the starting date of the event will be refunded by 50%. Cancellations made less than 2 weeks before the starting date of an event will not be refunded. If you are unable to attend, substitution with a colleague is possible and recommended.
QAdvis reserves the right to cancel the course due to low attendance, up until 2 weeks before the course start. You can contact us at any time to get a status update. If the course is cancelled, a full course fee refund will be offered, but no additional reimbursements. We reserve the right to change the agenda, time and location, up until 2 weeks before the course.
QAdvis reserves the right to change teachers or reschedule the course due to force majeure or due to teacher’s illness. No compensation will be paid for any additional costs incurred.
We are longtime trusted providers of MedTech quality and system management, risk management, compliance, training, interim management and regulatory affairs. Offering a thorough knowledge and understanding of the industry, based on 30 years of professional experience, QAdvis have the tools to help take your MedTech innovations to domestic and international markets.