Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

ISO14971:2019

 Specifies a process for the identification of hazards associated with device to:

● Estimate risk ● Evaluate risk ● Control risk ● Monitor effectiveness of these controls

The Organisation for Professionals in Regulatory Affairs

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GENERAL PRINCIPLES Risk Management

The Organisation for Professionals in Regulatory Affairs

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