Module 14: Design Development and Certification of Medical Devices

17/11/2023

Perform further evaluation based on chemical nature of materials, type and duration of contact

Selection of biological test

Testing or justification for omission

Conduct biological evaluation

The Organisation for Professionals in Regulatory Affairs

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Biological Evaluation

 Assess all available information  Assess required toxicological information  Identify gaps

The Organisation for Professionals in Regulatory Affairs

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