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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 2017 Conference & Expo

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Description:

AAMI 2017 is the premier conference for healthcare technology management. It is attended by more than 2,300 biomedical equipment technicians, clinical engineers, and others who manage or support medical devices for healthcare institutions. Educational sessions focus on 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. To visit the AAMI 2017 Home Page, click here.

Hotel Reservation Links: click here.

Start Date:
Friday, June 09, 2017
End Date:
Monday, June 12, 2017
Address:
The Austin Convention Center
500 East Cesar Chavez Street
Austin, TX 78701
UNITED STATES
AAMI Member
$0.00 - $850.00
List Price
$0.00 - $1,050.00


AAMI TIR12:2010

AAMI Member:
$125.00
List Price:
$222.00
Available for Immediate Download
↑/↓ Full Details


AAMI TIR14:2016

Contract sterilization using ethylene oxide
AAMI Member:
$67.00
List Price:
$119.00
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AAMI TIR15:2009/(R) 2013

Physical aspects of ethylene oxide sterilization.
AAMI Member:
$84.00
List Price:
$148.00
Available for Immediate Download
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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


AAMI TIR19:1998 and A1:1999 (PDF Format)

AAMI Member:
$59.00
List Price:
$104.00
Available for Immediate Download
↑/↓ Full Details


AAMI TIR20:2001

AAMI Member:
$84.00
List Price:
$148.00
Available for Immediate Download
↑/↓ Full Details


AAMI TIR28:2009/(R)2013

Product adoption and process equivalence for ethylene oxide sterilization
AAMI Member:
$67.00
List Price:
$119.00
Available for Immediate Download
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AAMI TIR29:2012

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 TIR32:2004/(R)2016

Medical device software risk management
AAMI Member:
$67.00
List Price:
$119.00
↑/↓ Full Details


AAMI TIR34:2014

Water for the reprocessing of medical devices
AAMI Member:
$131.00
List Price:
$222.00
Available for Immediate Download
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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 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
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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.
AAMI Member:
$315.00
List Price:
$415.00
Available for Immediate Download
↑/↓ Full Details


AAMI TIR48:2015

Quality Management System (QMS) Recommendations on the Application of the U.S. FDA's CGMP Final Rule on Combination Products
AAMI Member:
$146.00
List Price:
$258.00
Available for Immediate Download
↑/↓ Full Details