Addressing the uncertainty around implementation of the Medical Devices Regulation (MDR)
The new European regulations on medical devices entered into force in 2017 and must be fully implemented by 26th May 2020. As the deadline approaches, there is still a lot of confusion amongst device manufacturers about interpretation of the regulations and the practical implications. We have developed this training course in consultation with experts in devices vigilance in order to address the uncertainty and to provide clear practical guidance on handling the changes to vigilance requirements.
The course would be of interest to staff working in Quality Assurance, Regulatory Affairs, Post-market Surveillance, Vigilance, Device Safety, Drug Safety from both medical devices companies and pharma companies with drug-device combinations.
The course is led by Vigilance Expert, Fayez Abou Hamad who is MDR PMS and Vigilance leader at Terumo Europe in Belgium, as well as founder of “MDV-Solve” Medical Device Consulting Firm.
On successful completion of this course delegates will be able to:
- Demonstrate a good understanding of the MDR as a whole
- Provide an in-depth explanation of Vigilance Reporting and Field Safety Corrective Actions under MDR, as well as Periodic Summary Reports
- Be able to explain how to handle vigilance for drug-device combination products
Visit the course page to find out more and book your place.