Module 14: Design Development and Certification of Medical Devices

17/11/2023

Biological Assessments Relevant to Medical Devices

Stuart Freeman, Toxicology Consultant, Farino Consulting

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals in Regulatory Affairs

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Biological Assessment

• Biocompatability Assessment  • Toxicology Assessment  • Biological Safety 

Microbiological Safety X

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Clinical Effects X

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The Organisation for Professionals in Regulatory Affairs

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