Post-Market Surveillance and Vigilance for Medical Devices

Post-Market Surveillance and Vigilance for Medical Devices
Module 16 of the MSc (Medical Devices) and Masterclass. To define the terminology and explain the concepts of vigilance and post-market surveillance, their practical applications and integration into the lifecycle of a medical device. The focus is on meeting European requirements.
When: 28 February - 2 March 2018
Where: TOPRA, 6th Floor, 3 Harbour Exchange Square, South Quay, London, E14 9GE 



What is it?

This will include:

Learning outcomes:
  • Critically evaluate the requirements and guidance for post-market market surveillance
  • Critically evaluate the requirements and guidance and vigilance
  • Possess a systematic understanding and critical awareness of the European requirements including legislation, guidance and associated documentation relating to surveillance and vigilance for medical devices.

Skills and attributes:

  • Be able to critically appraise a PMS system and make recommendations on the implementation of a PMS system
  • Be able to make recommendations and vigilance procedures
  • Demonstrate the ability to critically analyse the legal requirements relating to surveillance and vigilance
  • Critically appraise and evaluate communications from competent authorities, notified bodies, economic operators and other stakeholders relating to the conduct of surveillance and vigilance.

 


Who is it for?
This course is suitable for anyone working in post-market surveillance and vigilance, or individuals involved in this area, who are interested in this area of medical devices and medicines and students completing their MSc in regulatory affairs (Medicines) or (Medical Devices). This will be a valuable course to ensure you are up to date with the current legislation and guidelines.

 

 

 

What will I learn?

This course will cover unique device identification and traceability in healthcare, the European requirements of post-market surveillance, risk management and CAPA, the Periodic Safety Update Report and vigilance reporting. It will also cover the role and responsibility of Notified Bodies, the PMCF plan and implementation of the plan, and public relations and communication and impact the legal considerations of medical devices.

Download course agenda
CPD: 20

How do I apply? 

Course fees:
Type Student Non-Student
Standard    £1500+VAT £1700+VAT 

Discounted places
A limited number of discounted places are available for those working in regulatory agencies, government bodies, charities or patient groups . Please email us for a discount code before making your booking.


 

Terms and conditions 
Please read the training terms and conditions before booking this course. By booking a place on this course you are agreeing to the training terms and conditions 


Travel and accommodation is not included. 
When
28/02/2018 - 02/03/2018
Where
TOPRA Office 6th Floor 3 Harbour Exchange South Quay London E14 9EG UNITED KINGDOM
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