Duration: 3.5 hours | 8:00 – 11:30 AM US Eastern Daylight Time (EDT), 2:00 – 5:30 PM Central European Summer Time (CEST)

Date: October 9th 2025, online
Speaker: Dr. Valentina Lintas

About the speaker:
Dr. Valentina Lintas is a regulatory and quality affairs biomedical engineer, with research expertise in the fields of tissue engineering and minimally invasive cardiovascular technologies and +5y experience in the Medtech industry. At Veranex, Valentina’s missions include review/redaction of technical documentation, regulatory pathways for medical devices and IVDs for EU and US, QMS audits, QMS review/ad-hoc support for compliance to European regulations. In addition, at Veranex Valentina acts as deputy PRRC under Swiss MedDO for the Swiss representative (CH-Rep) services.

Training objectives:
Understand the regulatory context of PRRC roles and responsibilities in both EU and CH regulations
Understand the qualification needed for selecting the PRRC within an organization
Understand in what situation(s) the role of the PRRC can be outsourced
Analyze the impact on the QMS documentation

Training content:
- Regulatory context and qualification requirements
Review of Article 15 requirements of MDR (EU 2017/745) and IVDR (EU 2017/746)
Review of Article 49, 51 requirements of Medical Device Ordinance (MedDO)
Review of Article 42, 45 requirements of Ordinance on In Vitro Diagnostic Medical Devices (IvDO)
Requirements regarding PRRC’s qualification

- Implementation of the requirements
Analysis of the roles and responsibilities of the PRRC
How to implement in practice the requirements from EU & CH regulations
Outsourcing and sharing the roles and responsibilities of the PRRC
Liability

- Impact on QMS documentation
Job description
Quality Manual
Human Resources process
Pos-market Surveillance and Vigilance processes
Design and Development and Manufacturing processes

Prerequisite:
Understanding of Quality Management Systems as per ISO 13485
Understanding of medical device regulatory framework in EU and CH

Training format: 
Presentation with interactive discussions
Exercises during the training
End of training assessment

Training certificate: 
Participants will receive a certificate on Person Responsible for Regulatory Compliance (PRRC) – EU & CH regulations upon successful completion of the end of training assessment.

Who should attend:
This course is designed for designated PRRCs, regulatory affairs professionals, quality assurance personnel, medical device manufacturers (particularly SMEs), EU Authorized Representatives, and consultants or advisors involved in EU medical device or IVD compliance - those responsible for ensuring conformity with MDR/IVDR requirements, preparing technical documentation, managing QMS and audits, or acting in a PRRC capacity either internally or on behalf of clients.

Price: 
EUR 345 incl. course material and certificate