The Medical Devices Introductory Course 2020

Conformity Assessment

TOPRA Medical Devices Introductory Course

A presentation by Howard Dobbs Howard Dobbs Consulting Ltd

The Organisation for Professionals in Regulatory Affairs

Learning Objectives

To understand: • the different conformity assessment options and how to select the most appropriate one for your product • the General Safety and Performance Requirements • the role of Harmonised Standards and Common Specifications • Technical Documentation • how to demonstrate conformity with the requirements of the Medical Devices Regulation (MDR) • how to get the CE mark

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

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