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A Comprehensive Overview of the Current FDA Guidances and International Standards for Medical Device Software

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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AAMI TIR12:2010

Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
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AAMI TIR12:2010 Red-line (PDF Format)

Includes Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers and red-line format of document showing changes between the current and 2004 version in red and strikethrough, PDF format.

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AAMI TIR18:2010

Guidance on electromagnetic compatibility of medical devices in healthcare facilities
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AAMI TIR36:2007 (PDF)

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AAMI TIR49:2013

Design of training and instructional materials for medical devices used in non-clinical environments
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AAMI TIR65:2015

Sustainability of medical devices-Elements of a responsible product life cycle
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AAMI/ISO TIR17137:2014 (PDF)

Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants
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AAMI/ISO TIR22442-4:2011/(R)2016

Medical devices utilizing animal tissues and their derivatives -- Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes.
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AAMI/ISO TIR23810:2012/(R)2015

Cardiovascular implants and artificial organs - Checklist for preoperative extracorporeal circulation equipment setup.
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AAMI/ISO TIR80002-2:2017 (PDF)

Medical device software—Part 2: Validation of software for medical device quality systems
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AAMI's Leadership Development Guide

A Resource for Healthcare Technology Management Professionals
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An FMEA Trifecta: sFMEA, dFMEA, & pFMEA (Webinar On Demand)

If you perform a System-Level Failure Mode & Effects Analysis (sFMEA), a Design FMEA (dFMEA), and a Process FMEA (pFMEA), then they can be linked to become a robust risk-analysis tool set. Linking these three tools can be considered a trifecta* • a safe bet on risk mitigation. A successful trifecta is great cause for celebration • risk and product managers can finally rest easy!
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An Overview of ANSI/AAMI/ISO 14155:2011: Clinical Investigation of Medical Devices for Human Subjects

Clinical studies are included in almost all new devices presented for premarket approval (PMA) to the U.S. Food and Drug Administration (FDA) and may also apply to the approximately 10% of devices under premarket notification that contain clinical data. ANSI/AAMI/ISO 14155:2011, Clinical investigation of medical devices for human subjects addresses the practical aspects of how to plan clinical investigations conducted in human subjects and defines procedures for the design, conduct, recording, and reporting of a clinical study. The latest version of the standard has been updated to provide step-by-step guidance on the creation and execution of a clinical study. This webinar will address good clinical practice in clinical investigations of medical devices for human subjects using ISO 14155 as a guide.
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ANSI/AAMI AT6:2013

Autologous transfusion devices.
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ANSI/AAMI BP22:1994/(R)2016

Blood Pressure Transducers
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ANSI/AAMI CI86:2017 (PDF)

Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
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ANSI/AAMI ST40:2004/(R)2018 (PDF)

Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities
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ANSI/AAMI ST58:2013 (PDF)

Chemical sterilization and high-level disinfection in health care facilities.
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