Requirements of the Medical Device Regulation (MDR) Training Course

Level Understanding Duration 1 day

Available to book: Public classroom HK$3360 Book your place

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

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

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
- 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.
- You will gain 8 CPD points on completing the course
- Training course notes
- Lunch
- Refreshments
Download course flyer (PDF)

Reach out and see how we can help guide you on your path to sustainable operational success.