Quality Management System (QMS) guidance on compliance with FDA's Final Rule on combination products

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

30-04-2024

Publisher

Association for the Advancement of Medical Instrumentation

€210.28

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This Technical Information Report (TIR) provides information about how to effectively implement the FDA’s regulation on current good manufacturing practices (CGMP) for combination products.

DocumentType	Standard
ISBN	978-1-57020-884-3
Pages	47
PublisherName	Association for the Advancement of Medical Instrumentation
Status	Current
Supersedes	AAMI TIR48:2015(R2021)

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AAMI TIR48:2024

Quality Management System (QMS) guidance on compliance with FDA's Final Rule on combination products

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AAMI TIR48:2024

Quality Management System (QMS) guidance on compliance with FDA's Final Rule on combination products

Abstract

General Product Information

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