Module 14 2022

22/03/2022

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

The Organisation for Professionals in Regulatory Affairs

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RISK MANAGEMENT

● Helps to assure safety of the device

● Contributes to the consistency of the manufacturing process.

● Identification of design problems before distribution eliminates costs associated with recalls.

● Offers a measure of protection from product liability damages

Masterclass: Lecture 2

The Organisation for Professionals in Regulatory Affairs

14

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