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. You will also gain eight CPD points and take away comprehensive training course notes.
How will I benefit?
This course will help you:
- Understanding of the European Medical Device Regulation
- Be able to explain the impact of the regulations within your organization
- Gain confidence, training notes and eight CPD points
The course is especially suitable for:
- 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.
- Please note: This course will not cover In Vitro Diagnostic Devices. Please refer to the ‘Related training’ below if you need more detailed information e.g. for implementation.
Prerequisites: There are no formal prerequisites for this course, but participants will benefit from a basic knowledge of Medical Devices use, design, or manufacture and/or general understanding of quality management.
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 the key steps of a conformity assessment
- Explain the main impacts on the quality management system (QMS) relating to MDR
- Recognize the requirements for post-market surveillance and updates
Our high impact accelerated learning approach increases learning by improving knowledge retention and skill application. This course is activity-based, resulting in a deeper understanding of the material and a greater impact on job performance.
This course will focus on the overall requirements of MDR, and not on specific devices or implementation issues.
- Detailed course notes and lunch are provided.
- On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.
- Loan copy of the standard (to be returned after the course)