Speaker: Koushik Ayalasomayajula
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 & 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
- Presentations with interactive discussions
- End of training assessment
Price
EUR 415 including course material and certificate