3 Day Seminar: An Introduction to the Medical Device Regulation (London, United Kingdom - May 14-16, 2018) - ResearchAndMarkets.com

DUBLIN--()--The "An Introduction to the Medical Device Regulation" conference has been added to ResearchAndMarkets.com's offering.

This course will help you gain a comprehensive understanding of the regulatory requirements.

This seminar provides a detailed introduction to the European medical device legislation. It will explain the Directives and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do. It will also cover the documentation necessary to apply for the CE Mark.

Key Topics

  • Learn the role of a Notified Body
  • Know what a Competent Authority expects
  • Better under Conformity Assessment Procedures, Classification, Medical Device legislation
  • Comply with Manufacturing Responsibilities
  • Consider the requirements for Quality Systems
  • Plan your Clinical Evaluations

Agenda

Day One

  • What is a medical device?
  • Europe and the Medical Device
  • What is a Competent Authority?
  • Classification of devices
  • Conformity Assessment Procedures
  • Workshop 1: Classification

Day Two

  • Manufacturer's responsibilities
  • Quality systems
  • Labelling of devices
  • Workshop 2: Labelling
  • Clinical evaluations
  • Workshop 3: Clinical evaluations

Day Three

  • Medical device vigilance
  • Workshop 4: Vigilance
  • Drug/Device combinations
  • Devices incorporating material of animal origin
  • The revision to the regulations for medical devices
  • Q&A session

For more information about this conference visit https://www.researchandmarkets.com/research/7wbqpk/3_day_seminar_an?w=4

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics: Medical Devices

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics: Medical Devices