Course description
This on-demand course will give you an understanding of the key requirements, which will provide:
- Essential knowledge to understand Regulatory Affairs of medical devices in the 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
- A basis to learn later about implementation of CE marking projects
Upcoming start dates
Choose between 2 start dates
Suitability - Who should attend?
The course is especially suitable for:
- New starters in Regulatory Affairs (RA) and those increasing their responsibility in this area, and RA professionals who are not familiar with the European MDR
- Anyone 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.
Outcome / Qualification etc.
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
Training Course Content
By the end of the course, you’ll 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 the 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
Course delivery details
- This is an online, interactive eLearning course
Request info
BSI Training
Kitemark Court, Davy Avenue, Knowlhill
MK5 8PP Milton Keynes
BSI, the British Standards Institution, is one of the world’s leading providers of training, certification, standards, regulatory approval, business improvement and management development for local and global audiences.
Our expert teams provide top quality training to organizations of all sizes and every type of industry - ranging from leading multinationals to small, innovative start-ups and from governments to charities. From understanding how a standard can help your business,...
Ads