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AAMI TIR38:2019

Medical device safety assurance case guidance
AAMI Member:
$133.00
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$236.00
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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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$155.00
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$274.00
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$274.00
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ANSI/AAMI/ISO 13485:2016

Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
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$133.00
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$236.00
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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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$38.00
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$62.00
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$62.00
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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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$134.00
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$134.00
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Leading Practice - Operational Qualification - Process Valid

This Leading Practice document discusses the central role of the operational qualification in establishing a well-controlled process during process validation. Failure to do this properly could result in poor product quality and recalls. It provides a framework of leading practices and examples of how to do the operational qualification properly.
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$40.00
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$68.00
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$68.00
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Leading Practice-Quality Mngmnt: Effective Training Prgms

This Leading Practice document is designed to help medical device firms better understand, implement, and comply with the training section of the Quality System Regulation 21 CFR 820.25(a) (b) as well as ISO 13485:2003 Section 6.2.2.
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$40.00
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$68.00
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$68.00
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Leading Practices - Management Responsibility

Leading Practices - Management Responsibility
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$40.00
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$68.00
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Leading Practices - Quality Audit

This Leading Practice discusses the need for manufacturers to conduct regular quality audits led by individuals not directly responsible for the matters being audited, with management review of audit results.
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$40.00
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$68.00
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$68.00
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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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$21.00 - $22.00
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Reliable Design of Medical Devices

Now in its Third Edition, this bestselling book shows you how to improve reliability in the design of advanced medical devices. Mirroring the typical product development process, the book provides an introduction to the basics of reliability engineering and failures, and then it takes you through the concept, feasibility, design, verification and validation, design transfer and manufacturing, and field activity phases.
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$164.00
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$220.00
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$220.00
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The Quality System Compendium: CGMP Requirements and Industry Practice, Third Edition

Since the 2007 publication of the second edition, there have been substantial changes in medical device technology, medical device regulatory approaches, and FDA and international guidances and standards. This new third edition has been developed to provide accurate and useful information to the medical device community, updated to reflect the current status of the many rapidly evolving areas of the medical device environment.

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$390.00
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$650.00
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$650.00
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