Vigilance of Medical Devices2020-02-04T11:04:11+00:00

Project Description

Vigilance of Medical Devices 

Course overview

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

Learning Outcomes

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

Key Topics

Programmed features:

  • 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

(Standard Registration)

Registration fee includes lunch, refreshments and electronic access to all course materials.

Download Course Programme

Click here to download the programme


Booking options


Course Leader 

Fayez Abou Hamad – MD, PMS & Vigilance Expert 

Fayez Abou Hamad is MDR PMS and Vigilance leader at Terumo Europe in Belgium, as well as founder of “MDV-Solve” Medical Device Consulting Firm. He is a pharmacist with more than 15 years’ experience in quality assurance within the pharmaceutical and medical device industry and has expertise in Clinical evaluation, Risk management, PMS and Vigilance & MDR implementation.

Contact Info

Drug Safety Research Unit Bursledon Hall, Blundell Lane, Southampton, SO31 1AA, U.K.

Phone: +44 (0)23 80 40 86 00

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