Module 18 2021
08/02/2021
Biological Assessment/Nonclinical Assessment
• Biocompatability Assessment
Device
Toxicology Assessment
Device/Drug
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Biological Safety
Device/Drug
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Microbiological Safety X
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Clinical Effects X
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The Organisation for Professionals in Regulatory Affairs
3
Guidelines – Medical Device
ISO 10993 • Provides guidance on how to perform biological evaluation of a device • Describes a matrix of toxicity endpoints that should be considered ISO 14971 • Application of risk management to medical device • Uses information produced in biological assessment to characterize risk
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The Organisation for Professionals in Regulatory Affairs
4
2
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