This one-day medical device training outlines the key requirements, concepts and overall process for CE marking under the medical device regulation. It’s suitable for anyone working in regulatory affairs/quality assurance or staff partnering with medical device manufacturers.
This stage of your learning journey creates a solid base for implementing your own CE marking projects. It provides essential knowledge about EU medical devices and regulatory affairs from all areas of an organization. It also explains the demands that fall on subcontractors, importers and distributors.
After completing this medical device training, you will have a sound understanding of the medical device regulation and be able to communicate it to others.
How will I benefit?
This course will help you:
- Understand the European Medical Device Regulation
- Be able to explain the impact of the regulations within your organization
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.
We also offer an equivalent training course for the requirements of the In Vitro Diagnostic Regulation.
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
What is included?
- A loan copy of the standard for use during the course
- Gain eight CPD points and take away comprehensive training course notes.
