Module 16 2022

05/09/2022

The Role & Responsibility of Notified Bodies in PMS & Vigilance

Theresa Jeary, Technical Specialist, BSI

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i Regulatory Affairs

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Learning Aims

• What is a Notified Body • Notified Body Assessment Process • Expectations for Post Market Surveillance & Vigilance • Common Errors

The Organisation for Professionals in Regulatory Affairs

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