Module 18 - Drug Device Combinations and Other Technologies

05/12/2023

Guidelines – Medical Device

ISO 14971 - Medical devices: Application of risk management to medical devices

Published 2019

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• Application of risk management to medical device

• Uses information produced in biological assessment to characterise risk

Not in scope • Decisions on use of a medical device in the context of a particular clinical procedure • Business Risk Management

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The Organisation for Professionals in Regulatory Affairs

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Guidelines – Drug Formulation

ICH M3 (R2) (2013) Non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals - Scientific guideline

In effect since 2009

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• Provides guidance on toxicology studies required to support clinical development/product registration

The Organisation for Professionals in Regulatory Affairs

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