AAMI TIR48 : 2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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QUALITY MANAGEMENT SYSTEM (QMS) RECOMMENDATIONS ON THE APPLICATION OF THE U.S. FDAS CGMP FINAL RULE ON COMBINATION PRODUCTS
Hardcopy , PDF
21-05-2021
English
01-01-2015
Glossary of equivalent standards
Committee representation
Introduction
1 Scope
2 Applying CGMPs in Accord with FDA's Final Rule
for Combination Products (21 CFR Part 4)
3 Considerations in transitioning
to 'Streamlined Approach'
4 Application of Design Controls and
Management for a Combination Product
Annex A - Terminology
Bibliography
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