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Clinical Evaluation of Medical Devices

Price

£1,700*

Location

At Your Desk

Date

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?

When?
19 June 2020

Where?
At Your Desk

*Cost

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.

Email info@topra.org

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