Date: 7th of November (1) and 14th of November (2) 2024 (2 sessions)
Time: 14:00h - 17:00h CET | 9am - 12pm EST
Location: Virtual
Language: English
Costs: € 895,- / $990
Introduction
The MDR and IVDR mandate that manufacturers and authorized representatives designate a Person Responsible for Regulatory Compliance (PRRC). Article 15 of both regulations outlines the necessary qualifications and responsibilities for this role, further clarified in the MDCG 2019-07 guidance document. To support organizations in appointing qualified PRRCs, Qserve offers a comprehensive 6-hour training, delivered across two sessions, specifically designed for individuals preparing to take on this responsibility.
Participants in this training have the option to receive a certificate upon successful completion, demonstrating qualification as a PRRC. The certificate details the learning objectives and verifies that the participant meets the MDR/IVDR requirements for PRRC qualification (experience and background). Personalized and audit-ready, the certificate can be presented to Notified Bodies as evidence of compliance. This optional certification is available for an additional fee of €375 / $425.
Learning Objectives
- Understand the background of MDR/IVDR to understand PRRC requirements and where they are coming fromWhat are the roles and responsibilities of PRRC.
- Qualifications of PRRC.
- Relation of PRRC and your QMS.
- Learn how to appropriately check the conformity of the devices.
- Understand what checks are proportionate to the risk class and the type of device.
- How to keep the technical documentation and the EU declaration of conformity up-to-date.
- Checks to fulfill for post-market surveillance obligations.
- Reporting obligations for recording and reporting of incidents and field safety corrective actions.
- What to do as PRRC if there are devices undergoing clinical investigation (MDR) or performance studies (IVDR).
- Liability of the PRRC.
Who Should Attend?- Persons that will be responsible for regulatory compliance
- Authorized representatives
- RA manager, RA director, QA manager, QA director
- Professionals preparing for the MDR/IVDR
Trainers(s):