Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Masterclass

Risk Management

Stuart Angell, Managing Director IVDeology Ltd

www.ivdeology.co.uk info@ivdeology.co.uk

ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION

The Organisation for Professionals in Regulatory Affairs

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Learning Outcomes

 Introduction to ISO 14971:2019  Principles of Risk Management  Risk Management of IVD Medical Devices

The Organisation for Professionals in Regulatory Affairs

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