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ANSI/AAMI/IEC 62304: 2006 & A1:2016 (Redline) (PDF)

Medical device software—Software life cycle processes
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ANSI/AAMI/IEC 62304:2006 & A1:2016 (PDF)

$137.00
$243.00
$243.00
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ANSI/AAMI/IEC 80001-1 • Successfully Launching an 80001-1-Based Program

ANSI/AAMI/IEC 80001-1:2010, Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities introduces a new framework for managing safety and security when medical devices are included on a convergent, heterogeneous IT-network. This approach not only identifies the activities necessary to maintain key properties of the network (safety, effectiveness, and security), it also identifies the roles that are needed and the collaboration necessary between a healthcare delivery organization and its networked technology suppliers.
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ANSI/AAMI/IEC 80001-1:2010

Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities.
$109.00
$192.00
$192.00
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AAMI/IEC TIR80001-2-1:2012

Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks; Practical applications and examples.
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AAMI/IEC TIR80001-2-2:2012

Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls.
$137.00
$243.00
$243.00

ANSI/AAMI/UL 2800-1:2019

Standard for Safety for Medical Device Interoperability
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$414.00
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Getting Started with IEC 80001 & 80001-1 Standard

Includes Getting Started with IEC 80001 handbook and ANSI/AAMI/IEC 80001-1, Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities.
$168.00
$280.00
$280.00

Getting Started with IEC 80001 & 80001-1 Standard (PDF)

Includes Getting Started with IEC 80001 handbook and ANSI/AAMI/IEC 80001-1, Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities. (PDF format)
$168.00
$280.00
$280.00
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Getting Started with IEC 80001

This handbook provides essential information for healthcare providers managing medical IT-Networks. It provides practical help to those getting started with their first 80001 projects, especially in acute care contexts.
$125.00
$209.00
$209.00
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Machine Learning AI in Medical Devices

Adapting Regulatory Frameworks and Standards to Ensure Safety and Performance
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Position Paper: Artificial Intelligence and Machine Learning

The emergence of artificial intelligence and machine learning in healthcare: Recommendations to support governance and regulation
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The Medical Connectivity FAQs

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Understanding and Benefiting from AAMI/IEC 80001-1

This webinar will help suppliers of medical devices, IT technology, and telecommunications understand the standard ANSI/AAMI/IEC 80001-1:2010.
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$85.00
$85.00
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Wi-Fi Enabled Healthcare

Focusing on its recent proliferation in hospital systems, Wi-Fi Enabled Healthcare explains how Wi-Fi is transforming clinical work flows and infusing new life into the types of mobile devices being implemented in hospitals.
$88.00
$111.00
$111.00