Training QP - Person Responsible for Regulatory Compliance

Qualified Person training Program 

MRM has a program of education for today's quality and regulatory affairs professional. If you want to improve your competence, enroll in our flexible quality and regulatory modules: 

  • Module 1 - EU Regulatroy Frameworks
  • Module 2 - EU Medical Device Design and Risk Management
  • Module 3 - Clinical Evaluation for Medical Devices
  • Module 4 - Developing and Maintaining Technical Documentation
  • Module 5 - Quality Management Systems for Medical Devices
  • Module 6 - Post-Market Surveillance and Vigilance for Medical Devices
  • Module 7 - Working with EU Regulatory Stakeholders as Part of the EU Conformity Assessment Process

Who Should Enroll?

  • Industry professionals representing product developers, manufacturers, distributors, service providers, entrepreneurs, investors and regulators dealing with medical device products, 
  • Whose work responsibilities include the preparation and management of medical device pre- and post marketing submissions to Competent Authorities 
  • Who prepare regulatory submissions to Competent Authorities and or Notified Bodies  
  • Engineering or life sciences graduates in the early stages of their regulatory careers. 
  • Professionals working for regulatory agencies

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  • UKRP-services
      The UK medical device regulatory system is independent of the European Economic Area (EEA). All medical device manufacturers will need to follow UK laws for (in vitro) medical devices, based on the EU regulations EU-MDR 2017/745 and EU-IVDR 2017/746. All non-UK manufacturers must have a UK-based UK Responsible Person (UKRP) designated and registered at the MHRA, and take the responsibility for the product in the UK. The UKRP is the equivalent of an EU Authorised Representative. UK-based manufacturers need to appoint an EU Authorized Representative. UK comprises England, Scotland, and Wales. Northern Ireland is part of the UK, but…