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This two-days 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.
This course will help you:
This training course is HRD Corp claimable programme.
By the end of the course, you’ll be able to:
The course is especially suitable for:
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.
Please note:
This course will not cover In Vitro Diagnostic Devices.
To qualify for the HRD Corp Claimable Course, your company must be registered with HRD Corp and comply with the grant requirements. We suggest consulting with your Human Resources team to confirm your eligibility and understand the application process. Once we receive your booking, our team will provide you with the necessary documents.
On completion, you will be awarded an internationally recognized BSI Training Academy certificate.
Reach out and see how we can help guide you on your path to sustainable operational success.