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Clinical Evaluation of Medical Devices




At Your Desk


19 Jun 2020

Reference No: T2005403-TOP

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Event Description

Course Outline:

To help you understand the broad scope of clinical investigation and the regulatory processes required with the alternative routes to demonstrate compliance.
The Masterclass will cover:

  • EU MDD 93.42 to WU MDR 2017/745
  • Who should perform the clinical evaluation
  • Clinical evaluation for marketed devices PMS/PMCF, PSUR and SSCP
  • The place of Clinical Evaluation within device life-cycle and tecnical documentation
  • The equivalence assessment under MDR
  • Clinical investigations under MDR
  • Types of clinical studies
  • ISO14155
  • Clinical global strategy requirements - US FDA Specifics

When & Where?

19 June 2020

At Your Desk


Course fee for Members: £1,700 plus 20% VAT
Course fee for Students: £1,500 plus 20% VAT

Applicant Requirements
  • Delegates from the healthcare regulatory affairs profession who wish to develop their knowledge of the requirements for the clinical evaluation of medical devices
  • Delegates from allied industries who wish to have a comprehensive understanding of the subject
Reference No: T2005403-TOP
TOPRA is the professional membership organisation for individuals working in healthcare regulatory affairs.
We work with our members internationally to enable and promote excellence across the healthcare regulatory profession.


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