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Course Details

Medical Technology Vigilance, Post-Market Surveillance and Risk Management


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Cranfield University
Cranfield Health
Contact Provider
Cranfield
Three days
Short Course
-
-
£1,300.00
Regulatory affairs professionals.
Cranfield University, Cranfield, MK43 0AL, Bedfordshire, United Kingdom

Aim

The course will define the terminology and explain the concepts of vigilance, post-market surveillance and risk management, their practical applications and integration into the lifecycle of a medical device.

This course is also Module 5 of the MSc in Medical Technology Regulatory Affairs and as such, would count towards the completion of the MSc if you were to successfully complete the assessments and enrol onto the qualification.

Course content

Topics covered include:

  • European Regulatory requirements for PMS, including recalls and vigilance
  • Responsibility for PMS - Competent Authorities, Notified Bodies and manufacturers
  • Other Regulatory requirements – eg US MDRs
  • Guidance documents for PMS, including Commission, Notified Body and Competent Authority documents
  • Key elements of PMS – reactive and pro-active
  • Tailoring PMS systems to specific products, including IVDs
  • Principles of ISO 14971 “Application of risk management to medical devices”
  • Requirements of ISO13485, Quality Management Systems standard
  • Feedback of PMS data into the risk management process
  • Exchange of information: PMS databases eg MAUDE and EUDAMED
  • GHTF Study Group II

Lectures will be delivered by a number of speakers from industry.

Course format

Three days including lectures and practical sessions

The course is also Module 5 of Medical Technology Regulatory Affairs MSc. This course has been developed in partnership with TOPRA (The Organisation for Professionals in Regulatory Affairs).




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