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AAMI TIR102:2019

U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems
$160.00
$282.00
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AAMI TIR38:2019

Medical device safety assurance case guidance
$137.00
$243.00
$243.00
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AAMI TIR48:2015

Quality Management System (QMS) Recommendations on the Application of the U.S. FDA's CGMP Final Rule on Combination Products
$160.00
$282.00
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AAMI/ISO 13485:2016, A Practical Guide

Medical Devices—A Practical Guide, Advice from ISO/TC 210
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ANSI/AAMI/ISO 13485:2016/(R)2019

Medical devices—Quality management systems—Requirements for regulatory purposes
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The Quality System Compendium, 4th edition (PDF)

CGMP Requirements and Industry Practice
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