Module 14: Design Development and Certification of Medical Devices

17/11/2023

Biological Evaluation

Toxicity Endpoints

• Systemic Toxicity – where absorption likely

• Sub-acute and Sub-chronic toxicity - Applicable when single or multiple exposures occur >24 h

• Genotoxicity - Mutations, damage to chromosomes

The Organisation for Professionals in Regulatory Affairs

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Biological Evaluation

Supplementary tests

• Chronic toxicity • Carcinogenicity • Reproductive and developmental toxicity

• Biodegradation • Immunotoxicity • Toxicokinetics

The Organisation for Professionals in Regulatory Affairs

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