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


  • 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


EUR 415 including course material and certificate


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