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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
AAMI Member:
$150.00
List Price:
$266.00
Available for Immediate Download
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ANSI/AAMI/ISO 13485:2016

Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
AAMI Member:
$129.00
List Price:
$229.00
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Assurance Cases for Medical Devices: Annual Updates from FDA and Industry Practitioners (Webinar On Demand)

Join a group of industry experts and FDA leaders as they explore assurance cases. Attendees will hear from FDA representatives in charge of reviewing assurance cases about common issues seen in submissions and the FDA's expectations. Attendees will also hear from industry experts about assurance case practices and emerging applications.
AAMI Member:
$119.00
List Price:
$199.00
Available for Immediate Download
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FDA Final Guidance for Infusion Pumps: Total Product Life Cycle and Safety Assurance Cases

The FDA recently released the final guidance for Infusion Pumps Total Product Life Cycle. With the final guidance, FDA lays out further details and clarification on safety assurance cases compared to the April 2010 draft guidance.
AAMI Member:
$119.00
List Price:
$199.00
Available for Immediate Download
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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.
AAMI Member:
$36.00
List Price:
$60.00
Available for Immediate Download
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ISO 13485:2016 Handbook (PDF)

Medical Devices - A Practical Guide. Advice from ISO/TC 210
AAMI Member:
$93.00
List Price:
$130.00
Available for Immediate Download
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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.
AAMI Member:
$38.00
List Price:
$66.00
Available for Immediate Download
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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.
AAMI Member:
$38.00
List Price:
$66.00
Available for Immediate Download
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Leading Practices - Management Responsibility

Leading Practices - Management Responsibility
AAMI Member:
$38.00
List Price:
$66.00
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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.
AAMI Member:
$38.00
List Price:
$66.00
Available for Immediate Download
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Medical Device Risk Management and Safety Assurance Cases

The FDA recently reported that class I recalls have increased from an average of 25 per year before 2008 to 50 in 2011 and 57 in 2012 (1). A class I recall is a situation in which there is a reasonable probability that use, or exposure to, a medical device will cause serious adverse health consequences or death. As the complexity and sophistication of medical technology and health care infrastructure continue to increase, assuring proper identification and adequate risk controls of these potential recall situations (i.e. hazardous situations) prior to the device being placed on the market is becoming more and more critical and challenging. How effective are the existing medical device risk management practices in assuring proper identification and controls of risks? Are there any gaps and opportunities? How can these gaps be addressed? What is FDA’s view on this issue?
AAMI Member:
$119.00
List Price:
$199.00
Available for Immediate Download
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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.
AAMI Member:
$21.00 - $22.00
List Price:
$35.00 - $38.00
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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.
AAMI Member:
$159.00
List Price:
$213.00
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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.

AAMI Member:
$390.00
List Price:
$650.00
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