Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

• The manufacturer should consider the design characteristics relating to safety • Risk analysis should consider foreseeable hazards relating to both the intended purpose and any circumstances of reasonable foreseeable misuse • User? • Analyte detected? • Intended use environment? • Operating principle? • Assessment should be conducted throughout the device life-cycle

The Organisation for Professionals in Regulatory Affairs

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RISK MANAGEMENT Practical Implementation

The Organisation for Professionals in Regulatory Affairs

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