Introduction to Regulatory Affairs for Medical Devices

This practical 2-day introductory-level training course will examine the complex processes involved in meeting the EU regulatory requirements associated with  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

From early decisions regarding the most appropriate conformance route of a product, through to post marketing adverse event reporting, delegates will learn which regulations directly apply to their product and what steps need to be taken to achieve full compliance and ensure patient safety.

• 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