The Medical Devices Introductory Course 2020

Principles of Medical Device Regulation in Europe – Topics Covered:

The changing legislative environment in the EU (MDR and MDD)

Classification, conformity assessment, quality management systems, standards, technical documentation, general safety & performance requirements [“The Route to the CE Mark”]

Clinical evaluation and investigation

Risk management, post-market requirements and vigilance

Drug-device borderline and combination products

In-vitro diagnostics.

The Organisation for Professionals in Regulatory Affairs

Course / Module Team:

Sarah Roberts – Conference & Accreditation Lead (TOPRA) Kay Platt – Education & Apprenticeship Lead (TOPRA) Laura Brown – Course Director (TOPRA) Samantha Cooper – Director of Professional Development (TOPRA) Jonathan Hughes – Module Advisor / Chair / Speaker (Consultant, JHRA Ltd) Theresa Jeary – Speaker (Consultant, Reg & Scientific Affairs Ltd) Howard Dobbs – Speaker (Consultant, Howard Dobbs Consulting Ltd) Rachel Hattersley Dykes – Speaker (Medical Writer, Dev Done)

Simon Richards – Speaker (VP RA , Abbott Rapid Dx) Priya Tiwari – Speaker (Assoc. Dir. RA (CMC), Biogen) Peter Bowness – Speaker (Technical Team Manager, BSI)

The Organisation for Professionals in Regulatory Affairs