Vigilance of Medical Devices
Venue: Novotel London West Hotel, Hammersmith, London W6 8DR
Date: Wednesday 11 March 2020
With less than six months until full implementation of the Medical Device Regulations (MDR), there is still a lot of confusion amongst manufacturers about interpretation of the regulations and the practical implications. We have developed this training course to help address this uncertainty.
*Please note that the course dates and programme may be subject to change.
Who should attend?
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.
Aims of course
- To provide an overview of the Medical Devices Regulation (MDR)
- To instil an in-depth understanding of Vigilance Reporting and Field Safety Corrective Actions under MDR
- To ensure an understanding of Periodic Summary Reports
- To explain how to handle vigilance for drug-device combination products
- To support delegates’ learning by providing case studies from a large devices company
On successful completion of this course delegates should be able to:
- Demonstrate a good understand 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
- Overview of the Medical Devices Regulation (MDR)
- Vigilance reporting under MDR
- Field Safety Corrective Actions under MDR
- Periodic Summary Reports
- Vigilance for drug-device combination products
£387 + VAT Academic
(Academic Units, Public Sector Organisations, Registered Charities)
£595 + VAT Standard
Registration fee includes lunch, refreshments and electronic access to all course materials.
Download Course Programme
Click here to download the programme