Module 14: Design Development and Certification of Medical Devices

17/11/2023

Biological Assessment Summary

 Key Purpose to assure safety of patient or user  Not a tick box exercise. Requires individual consideration of data needs  Use WoE approach and existing data to minimise requirement for new studies  Identify/evaluate leachables and degradants  Report should provide an expert integrated review of data and definitive opinion on safety of device

The Organisation for Professionals in Regulatory Affairs

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Thank You

The Organisation for Professionals in Regulatory Affairs

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