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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  • BREXIT impact
    How medical devices are currently regulated All medical devices are subject to EU legislation, which requires a manufacturer to place a CE mark on their product to attest compliance to applicable standards. Medical devices are regulated under Directive 90/385/EEC on active implantable medical devices (AIMDD), Directive 93/42/EEC on medical devices (MDD) and Directive 98/79/EC on in vitro diagnostic medical devices (IVDD). These directives are transposed into UK law as the Medical Devices Regulations 2002. Manufacturers of low-risk devices (Class I medical devices) can self-declare conformity to the legislation before affixing the CE mark. Higher-risk devices (such as Class IIa, IIb…