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An Introduction to the Medical Device Regulation


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Who should attend?

Past delegates include personnel from the following departments: Regulatory Affairs Pharmacovigilance Quality Assurance Technical Support This seminar will be of interest to all personnel who are new to the medical device industry, all those who intend to place a medical device on the market and anyone who requires an overview of the medical device sector

Details

Course Overview

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.

This is an excellent introduction from leading experts in the field and delegates should expect three comprehensive days of training.

Why you should attend

  • Understand the new Medical Device Regulation (MDR) n Learn the role of a Notified Body
  • Know what a Competent Authority expects
  • Hear more on classification
  • Better understand Conformity Assessment Procedures n Comply with manufacturing responsibilities
  • Discover medical device vigilance
  • Plan your clinical evaluations
  • Discuss Drug/Device combinations

Who should attend

Past delegates include personnel from the following departments:

  • Regulatory Affairs
  • Pharmacovigilance
  • Quality Assurance
  • Technical Support

This seminar will be of interest to all personnel who are new to the medical device industry, all those who intend to place a medical device on the market and anyone who requires an overview of the medical device sector

Prices

TBC

Contact

Leigh White
info@management-forum.co.uk

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