Introduction to Regulatory Affairs for Medical Devices

The European Commission are currently undertaking a further complete Revision (Recast) of the regulatory requirements. Learn about these proposals and the latest developments and how these will affect you in the future.

Course Highlights
•Gain a complete overview of the latest MDD regulations.
•Determine the most appropriate conformance route for your products.
•Meet the requirements for clinical data evaluation.
•Examine the role of risk management throughout the lifecycle of your medical devices.
•Work effectively with EU Regulators to gain clarification.