Requirements of the Medical Device Regulation (MDR) Training Course

This course is now available online

 

The course will give you an understanding of the key requirements, which will provide: 

  • Essential knowledge to understand Regulatory Affairs of medical devices in EU, e.g. in the position of top management, or a manager or project member in QM/QA, R&D, design, manufacturing, supply chain, customer service and sales
  • The ability to understand the demands of the subcontractor, supplier, OEM, authorized representative, importer, distributor, allowing better relationships between them and the legal manufacturer

Who should attend?

  • New starters in Regulatory Affairs (RA), personnel increasing their responsibility in this area, and RA professionals who are not familiar with the European MDR
  • Personnel working with Regulatory Affairs departments, e.g. top management, manager or project member in QM/QA, R&D, design, manufacturing, supply chain, customer service and sales
  • Staff working for organizations that partner with Medical Device manufacturers, e.g. as subcontractor, supplier, OEM, authorized representative, importer, distributor, auditee etc. 

What will I learn?

By the end of the course delegates will be able to:

  • Communicate the key requirements and concepts within the Regulation
  • Reference the necessary aspects to evaluate if and how your company is affected by MDR and to what extent
  • Define the vocabulary used within MDR
  • Explain the structure and administration of the Regulation
  • Recognize partners of manufacturers affected by the Regulation
  • Describe key steps of a conformity assessment
  • Explain the main impacts on the QMS relating to MDR
  • Recognize requirements for post-market surveillance and updates 

How will I benefit?

This course will help you:

  • Understand the key requirements and concepts of the European Medical Devices Regulation
  • Communicate the impact of the key requirements introduced by the MDR to your organization

 

What's included?

  • You will gain 8 CPD points on completing the course
  • Training course notes
  • Lunch
  • Refreshments