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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
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$155.00
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$274.00
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AAMI TIR38:2019

Medical device safety assurance case guidance
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$133.00
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$236.00
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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
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ANSI/AAMI/ISO 13485:2016/(R)2019

Medical devices—Quality management systems—Requirements for regulatory purposes
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FDA's Guide to Inspections of Quality Systems

A handbook for device manufacturers to prepare for the FDA's inspection process, Quality Systems Inspections Technique (QSIT). Featuring "must know" flow charts and checklists.
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ISO 13485:2016 Handbook (PDF)

Medical Devices - A Practical Guide. Advice from ISO/TC 210
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$96.00
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Quality System Regulation (21 CFR Parts 808, 812 & 820)

Full text of the Final Rule of FDA's GMP for medical devices, as it appeared in the Federal Register.
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$22.00
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$38.00
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The Quality System Compendium

CGMP Requirements and Industry Practice, Fourth Edition
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$390.00
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$650.00
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The Quality System Compendium, 4th edition

CGMP Requirements and Industry Practice
AAMI Member:
$390.00
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$650.00
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$650.00
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