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Introduction To Medical Device Regulation in Europe

Price

£1,700*

Location

Chesham, Buckinghamshire, UK

Date

13 Jun 2018 - 15 Jun 2018

Reference No: T1804296-TOP

Apply for this event

Key points about this Training Event

  • The role of the essential requirements / harmonised standards and how to demonstrate conformity
  • The different conformity assessment routes and how to select the most appropriate route for their product
  • The role of risk management in pre and post market phase and be able to advise on a risk management policy and procedure
  • The need for clinical evidence for CE marking
  • The needs of payers and how to include these as part of the development of the device regulatory package
  • The key elements within a PMS system
  • The criteria for vigilance and the Competent Authority (CA) expectations
  • The minimum requirements and CA expectations for implementing an FSCA
  • The impact of marketing literature on regulatory status
  • The unique requirements of the IVD Directive
Event Description


Course Outline:

This newly researched and updated course is demanded by regulatory affairs managers who wish to get their people up to speed on current European medical device regulatory practices. 

When & Where?

When:
13 June 2018 - 15 June 2018

Where:
De Vere Latimer Estate 
Chesham
Buckinghamshire
HP5 1UG

*Cost?

Course fee for Members: £1,500 plus 20% VAT
Course fee for Non-member: £1,700 plus 20% VAT 
 

Applicant Requirements
  • Anyone needing to get up to speed on current European medical device regulatory practices
Reference No: T1804296-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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