Module 15 Presentations

4/15/2024

Lecture 3: The Place of Clinical Evaluation Within Device Life-Cycle and Technical Documentation

Presented by:

Adrian Keene, Associate Vice President, Global Biological Safety and Validation and EMEA Consulting Services

Date:

April 2024

© NAMSA 2021

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MDR Article 2 (44) Clinical Evaluation

a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance , including clinical benefits of the device when used as intended by the manufacturer.

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© NAMSA 2021

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