The course will begin once you click on “start”. The course is self-paced and breaks can be taken at any time. Your progress will automatically be saved and you can continue from where you left off whenever you resume the course.
A reliable internet connection is required to access the course, and we advise you choose a time and a place where you will not be disturbed to undertake the training.
You will be able to access the training for 12 months from the time this email is issued, so please ensure you complete the Elearning in advance of this time.
We really hope you enjoy your BSI Training Academy eLearning course. Please contact us if you have any queries.
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
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
What's included?
On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.
