Module 14: Design Development and Certification of Medical Devices

17/11/2023

Biological Evaluation

Types of tests

• In vitro - Cytotoxicity, mutagenicity, irritancy

• In vivo - Systemic toxicity, carcinogenicity, reprotox

• In silico - Computer models to predict toxicity

The Organisation for Professionals in Regulatory Affairs

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Biological Evaluation

Impurities

• Leachables

• Extractables

• Degradants

The Organisation for Professionals in Regulatory Affairs

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