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Medical Device Cybersecurity

A Guide for HTM Professionals
AAMI Member:
$155.00
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$232.00
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$232.00
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Medical Device Cybersecurity (PDF)

A Guide for HTM Professionals
AAMI Member:
$155.00
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$232.00
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$232.00
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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
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Premarket Risk Management

For New Medical Device Companies
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$117.00
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$153.00
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$153.00
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Preventing Medical Device Recalls

A critical and often overlooked aspect of preventing medical device recalls is the ability to implement systems thinking. Although systems thinking won’t prevent every mistake, it remains one of the most effective tools for evaluating hidden risks and discovering robust solutions for eliminating those risks.

Written by Dev Raheja, MS, CSP.
Published July 25, 2014 by CRC Press.
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$79.00
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$108.00
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$108.00
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Risk and Reliability in Healthcare and Nuclear Power: Learning from Each Other

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$35.00
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$60.00
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$60.00
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Risk and Reliability in Healthcare and Nuclear Power: Learning from Each Other (PDF Format)

AAMI Member:
$35.00
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$60.00
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$60.00
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Spring 2014 Horizons: Cybersecurity in Healthcare: What You Need to Know

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$22.00
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$36.00
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$36.00
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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
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$650.00
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$650.00
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Validation of a Medical Device Cleaning Process

There is increased focus by regulators around the world on medical device cleaning processes, and many medical device manufacturers find it a considerable challenge to plan and conduct a cleaning validation. The main challenges are an establishment of the cleanliness limits and an identification of the challenge conditions to be assessed during the process validation. This webinar describes logical and risk-based approaches to overcome these challenges.
AAMI Member:
$149.00
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$249.00
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$249.00
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Writing an Effective Human Factors Engineering Procedure

This webinar discusses the need for medical device companies to create a human factors engineering (HFE) procedure that conforms to current HFE standards as well as the standards and expectations of the FDA and other regulators. Learn how an HFE procedure must be closely tied to a company’s risk management process (e.g., ISO 14971) and ways to turn a general procedure into a detailed and properly scaled one to guide a particular product development effort. This webinar serves the remedial benefit of explaining the purpose of the myriad HFE activities comprising a complete procedure. This webinar will enable audience members to immediately prepare appropriate procedures for their own organization.
AAMI Member:
$135.00
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$225.00
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$225.00
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