Module 14: Design Development and Certification of Medical Devices
17/11/2023
RISK MANAGEMENT AND RISK ASSESSMENT
November 2023
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RISK MANAGEMENT
◦ Not new – always been required by law ◦ Within the medical device regulations ◦ As a key feature of : ◦ ISO 13485 : Quality Management Systems ◦ ISO 14971…
Masterclass: Lecture 2
6
3
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