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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
- Understanding Quality Management Systems as per ISO 13485
- Understanding the medical device regulatory framework in the EU and CH
Training Format:
- Presentation with interactive discussions
- Exercises during the training
- End of training assessment (participants will receive a training certificate)
Who Should Attend:
- Managers and employees working in Quality Assurance or Regulatory Affairs departments of medical device manufacturing companies
- Managers and employees working in Research and Development departments of medical device manufacturing companies
- Technical medical device consultants and associates
- Auditors of medical devices