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Special Topics in Medical Devices in the EU
Short course
In Bedfordshire ()
Description
-
Type
Short course
Delegates will learn to determine which regulatory framework applies and understand the principles of bringing products to market under the different frameworks. The module will focus upon European requirements and will emphasize the requirements for ‘borderline’ products, especially drug-device combinations.
Reviews
Subjects
- Medical
- Medical training
Course programme
What you will learn
On completion of the three-day course delegates should be able to:
- Critically evaluate factors that might be used to select a regulatory framework for a particular product (eg. as a cosmetic, a device or a medicine)
- Critically analyse and apply the development of strategies for CE Marking medical devices incorporating medicinal products
- Critically evaluate the principals that influence and determine the regulatory designation of borderline products
- Describe the European regulatory framework for some important types of medical products
- Advise on submission requirements for CE marking.
Special Topics in Medical Devices in the EU