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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
List Price:
$415.00
Available for Immediate Download
↑/↓ Full Details


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
Available for Immediate Download
↑/↓ Full Details


AAMI 2018 Conference & Expo

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Description:

AAMI 2018 is the premier conference for healthcare technology management. It is attended by nearly 3,000 biomedical equipment technicians, biomedical and clinical engineers, clinicians, HTM and biomedical engineering faculty and students, and others who manage or support medical devices for healthcare institutions. Educational sessions focus on cybersecurity, project management, risk management and practical solutions for the challenges that attendees face in their work every day. The Expo provides an opportunity to see the latest technologies from many of the world's leading medical-equipment manufacturers and service providers. Visit the AAMI 2018 Home Page.

Hotel Reservation Link

Start Date:
Friday, June 01, 2018
End Date:
Monday, June 04, 2018
Address:
Long Beach Convention Center
300 East Ocean Blvd
Long Beach, CA 90802
UNITED STATES
AAMI Member
$0.00 - $750.00
List Price
$0.00 - $950.00


AAMI RT2:2017 (PDF)

Radiation therapy readiness check
AAMI Member:
$0.00
List Price:
$0.00
Available for Immediate Download
↑/↓ Full Details


AAMI TIR12:2010

Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
AAMI Member:
$125.00
List Price:
$222.00
↑/↓ Full Details


AAMI TIR14:2016

Contract sterilization using ethylene oxide
AAMI Member:
$67.00
List Price:
$119.00
↑/↓ Full Details


AAMI TIR15:2016 (PDF)

Physical aspects of ethylene oxide sterilization
AAMI Member:
$84.00
List Price:
$148.00
Available for Immediate Download
↑/↓ Full Details


AAMI TIR16:2009/(R) 2013

Microbiological aspects of ethylene oxide sterilization.
AAMI Member:
$84.00
List Price:
$148.00
Available for Immediate Download
↑/↓ Full Details


AAMI TIR18:2010

Guidance on electromagnetic compatibility of medical devices in healthcare facilities
AAMI Member:
$125.00
List Price:
$222.00
Available for Immediate Download
↑/↓ Full Details


TIR19 & A1 Combined

Guidance for ANSI/AAMI/ISO 10993-7:1995, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
AAMI Member:
$59.00
List Price:
$104.00
↑/↓ Full Details


AAMI TIR20:2001

Parametric release for ethylene oxide sterilization
AAMI Member:
$84.00
List Price:
$148.00
↑/↓ Full Details


AAMI TIR28:2016 (PDF)

Product adoption and process equivalence for ethylene oxide sterilization
AAMI Member:
$67.00
List Price:
$119.00
Available for Immediate Download
↑/↓ Full Details


AAMI TIR29:2012/(R)2017 (PDF)

Guide for process characterization and control in radiation sterilization of medical devices
AAMI Member:
$118.00
List Price:
$208.00
Available for Immediate Download
↑/↓ Full Details


AAMI TIR34:2014

Water for the reprocessing of medical devices
AAMI Member:
$131.00
List Price:
$222.00
Available for Immediate Download
↑/↓ Full Details


AAMI TIR37:2013

Sterilization of health care products—Radiation—Guidance on sterilization of biologics and tissue-based products
AAMI Member:
$67.00
List Price:
$119.00
Available for Immediate Download
↑/↓ Full Details


AAMI TIR38:2014

Medical device safety assurance case guidance
AAMI Member:
$125.00
List Price:
$222.00
Available for Immediate Download
↑/↓ Full Details


AAMI TIR39:2009/(R)2017 (PDF)

Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices
AAMI Member:
$67.00
List Price:
$119.00
Available for Immediate Download
↑/↓ Full Details


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
AAMI Member:
$67.00
List Price:
$119.00
↑/↓ Full Details


AAMI TIR45:2012

Guidance on the use of agile practices in the development of medical device software
AAMI Member:
$131.00
List Price:
$222.00
Available for Immediate Download
↑/↓ Full Details


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.
AAMI Member:
$315.00
List Price:
$415.00
Available for Immediate Download
↑/↓ Full Details