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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.
AAMI Member:
$315.00
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$415.00
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A Guide for Medical Device Manufacturers: Understanding and Applying the FDA Processes, Terminology, and Informational Databases for U.S. Medical Device Classification (Webinar On Demand)

This webinar provides a comprehensive overview of the FDA processes, terminology, and informational databases established for U.S. medical device classification.
AAMI Member:
$315.00
List Price:
$415.00
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AAMI RT2:2017 (PDF)

Radiation therapy readiness check
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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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$125.00
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$222.00
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AAMI TIR14:2016

Contract sterilization using ethylene oxide
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$67.00
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$119.00
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AAMI TIR15:2016 (PDF)

Physical aspects of ethylene oxide sterilization
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$84.00
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$148.00
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AAMI TIR16:2009/(R) 2013

Microbiological aspects of ethylene oxide sterilization.
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$84.00
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$148.00
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AAMI TIR18:2010

Guidance on electromagnetic compatibility of medical devices in healthcare facilities
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$125.00
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$222.00
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AAMI TIR19:1998 and A1:1999 (PDF Format)

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$59.00
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$104.00
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AAMI TIR20:2001

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$84.00
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$148.00
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AAMI TIR28:2016 (PDF)

Product adoption and process equivalence for ethylene oxide sterilization
AAMI Member:
$67.00
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$119.00
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AAMI TIR29:2012/(R)2017 (PDF)

Guide for process characterization and control in radiation sterilization of medical devices
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$118.00
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$208.00
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AAMI TIR34:2014

Water for the reprocessing of medical devices
AAMI Member:
$131.00
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$222.00
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AAMI TIR37:2013

Sterilization of health care products—Radiation—Guidance on sterilization of biologics and tissue-based products
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$67.00
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$119.00
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AAMI TIR38:2014

Medical device safety assurance case guidance
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$125.00
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$222.00
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AAMI TIR41:2011/(R)2017

Active Implantable Medical Devices - Guidance for Designation of Left Ventricle and Implantable Cardioverter Defibrillator Lead Connectors and Pulse Generator Connector Cavities for Implantable Pacemakers and Implantable Cardioverter Defibrillators
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$67.00
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$119.00
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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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$131.00
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$222.00
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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 TIR48:2015

Quality Management System (QMS) Recommendations on the Application of the U.S. FDA's CGMP Final Rule on Combination Products
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$146.00
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$258.00
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AAMI TIR51:2014

Human factors engineering – Guidance for contextual inquiry
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$67.00
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$119.00
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