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80001 TIRs (Set of 4 Publications - PDF Format)

The set of all four TIRs to aid users in applying 80001-1, Application of risk management for IT Networks incorporating medical devices. This set includes 80001-2-1:2012, 80001-2-2:2012, 80001-2-3:2012, and 80001-2-4:2012 (PDF format).
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$195.00
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$413.00
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80001 TIRs (Set of 4 Publications)

The set of all four TIRs to aid users in applying 80001-1, Application of risk management for IT Networks incorporating medical devices. This set includes 80001-2-1:2012, 80001-2-2:2012, 80001-2-3:2012, and 80001-2-4:2012
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$234.00
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$413.00
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A Comprehensive Overview of the Current FDA Guidances and International Standards for Medical Device Software (Webinar On Demand)

With the extensive and rapidly evolving use of software in today’s medical devices, it is important for industry professionals to understand the implications of regulatory requirements for medical device software and to be aware of the many guidances and standards that are available to industry on this important topic.
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$415.00
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AAMI Standards on CD - IT

This new collection is your one-stop resource for 80001 and Medical Device Data System (MDDS) guidance. Searchable and easy to use, it includes 14 standards, 5 related webinars, and other resources.

For more info on the contents of this collection, click here.

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$495.00
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AAMI TIR36:2007

Validation of software for regulated processes
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AAMI TIR45:2012

Guidance on the use of agile practices in the development of medical device software
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AAMI TIR45:2012, Guidance on the use of AGILE practices in the development of medical device software (Webinar On Demand)

This webinar archive provides detailed information about AAMI TIR45:2012, Guidance on the use of AGILE practices in the development of medical device software and its recommendations for complying with international standards and FDA guidance documents when using AGILE practices to develop medical device software.
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$315.00
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$415.00
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AAMI TIR57: Principles for Medical Device Security--Risk Management (Webinar On Demand)

This webinar, led by the co-chairs of the committee who developed TIR57, outlines the document and its application to your business. TIR57 provides guidance for addressing information security within the risk management framework defined by ANSI/AAMI/ISO 14971.
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AAMI/IEC TIR80001-2-8:2016 (PDF)

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$125.00
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$222.00
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AAMI/IEC TIR80002-3: 2016 (PDF Version)

Technical Information Report Medical device software—Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
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ANSI/ AAMI/IEC 62304:2006/ A1:2015 (PDF)

Medical device software— Software life cycle processes.

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ANSI/AAMI SW87:2012

Application of Quality Management System concepts to Medical Device Data Systems (MDDS).
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ANSI/AAMI/IEC 62304:2006 & A1:2016

Medical device software - Software life cycle processes. Replaces ANSI/AAMI SW68
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ANSI/AAMI/IEC 80001-1:2010 (GS Kit Version)

Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities, Getting Start kit version.
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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.
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ANSI/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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ANSI/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.
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ANSI/AAMI/IEC TIR80001-2-3:2012

Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks
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ANSI/AAMI/IEC TIR80001-2-4:2012

Application of risk management for IT-networks incorporating medical devices -- Part 2-4: General implementation guidance for healthcare delivery organizations.
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ANSI/AAMI/IEC TIR80001-2-5:2014

Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance for distributed alarm systems
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