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Essentials of European Medical Device Regulatory Affairs

Price

£360

Location

Ireland

Date

21 Jun 2018

Reference No: T1802223 - TOP

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Key points about this Training Event

  • What is and what is not a medical device
  • The European legislation and guidelines concerning medical devices
  • The role of the competent authority
  • The role of the notified body
  • The classification of medical devices
  • The “Essential requirements” of a medical device
  • The documentation that is required to support a medical device
  • The declaration of conformity and the CE mark Device labelling
  • Clinical evaluation
  • Post-marketing activities
Event Description

Course outline:

The aim of the course is to provide an insight into the regulatory requirements for Medical Devices in the EU. Whether you are a new recruit working regulatory affairs for devices or an experienced regulatory professional in the world of medicines, this course will give you the overview you need. 

Skills and Attributes:

Regulatory affairs professional who requires a comprehensive overview of medical devices regulatory affairs
Professionals who work in functions allied to medical device regulatory affairs such as marketing, medical, quality, packaging, legal etc
Those working in an administrative capacity alongside medical device regulatory affairs requiring an overview of device regulatory affairs and those returning to work after a career break

Travel is not included

When and Where?

When:
21 June 2018

Where:
Basics of Medical Devices Regulatory Affairs
Ireland

Cost?

Course fee for Students of the MSc Regulatory Affairs: £360.00 plus 23% VAT

This does not include travel or accomodation

 

Applicant Requirements
  • Regulatory affairs professional who requires a comprehensive overview of medical devices regulatory affairs
  • Professionals who work in functions allied to medical device regulatory affairs such as marketing, medical, quality, packaging, legal etc
  • Those working in an administrative capacity alongside medical device regulatory affairs requiring an overview of device regulatory affairs and those returning to work after a career break
Reference No: T1802223 - 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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