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Industrial Sterilization: Research from the Field

This book presents 11 articles from leading experts on Industrial Ethylene Oxide Sterilization, Microbiological Methods, Steam Sterilization, and Quality Management Systems and Sterility Assurance.
AAMI Member:
$70.00
List Price:
$116.00
Your Price:
$116.00
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Industrial Sterilization: Research from the Field (PDF)

This book presents 11 articles from leading experts on Industrial Ethylene Oxide Sterilization, Microbiological Methods, Steam Sterilization, and Quality Management Systems and Sterility Assurance. PDF format.
AAMI Member:
$70.00
List Price:
$116.00
Your Price:
$116.00
Available for Immediate Download
↑/↓ Full Details


Integrating Risk Management into the Product Life Cycle

http://my.aami.org/aamiresources/images/events/901-Glebe.jpg
  • Understand risk management concepts used throughout the quality system to successful meet FDA, ANSI/AAMI/ISO 14971, and ANSI/AAMI/ISO 13485:2016 requirements
  • Learn how to use risk management to make risk-based decisions for product realization, from cradle to grave

Registration Fees:

  • AAMI Members: $2340
  • Nonmembers: $2600
  • Government Employees: $935

Start Date:
Tuesday, August 18, 2020
End Date:
Thursday, August 20, 2020
Time:
8:00 AM - 5:00 PM Eastern Daylight Time
Address:
AAMI Center for Excellence (ACE)
901 North Glebe Road Suite 300
Arlington, VA 22203
UNITED STATES
AAMI Member
$935.00 - $2,340.00
List Price
$935.00 - $2,600.00


Integrating Risk Management into the Product Life Cycle

http://my.aami.org/aamiresources/images/events/901-Glebe.jpg
  • Understand risk management concepts used throughout the quality system to successful meet FDA, ANSI/AAMI/ISO 14971, and ANSI/AAMI/ISO 13485:2016 requirements
  • Learn how to use risk management to make risk-based decisions for product realization, from cradle to grave

Registration Fees:

  • AAMI Members: $2340
  • Nonmembers: $2600
  • Government Employees: $935

Start Date:
Tuesday, March 10, 2020
End Date:
Thursday, March 12, 2020
Time:
8:00 AM - 5:00 PM Eastern Daylight Time
Address:
AAMI Conference Center, 901 North Glebe Road, Suit
901 North Glebe Road, Suite 300
Arlington, VA 22203
UNITED STATES
AAMI Member
$935.00 - $2,340.00
List Price
$935.00 - $2,600.00


International Standards Conference 2020

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The International Conference on Medical Device Standards and Regulation will be held Monday, 20 April - Wednesday, 22 April. In its 30th year, the conference is being expanded to include pre-conference symposia on Monday, 20 April on corporate standards management best practice and on the European Medical Device Directives. The main conference will begin Monday afternoon following the symposia, and continue Tuesday and Wednesday, 21-22 April. A post-conference workshop is scheduled for Thursday, 23 April with more information forthcoming in January 2020.

After selecting your registration option for the main conference, select Add next to the pre- and post-conference sessions you would like to attend. (You must first register for the main conference in order to register for pre- and post-conference sessions.)

To register another member from your organization, click Register Someone Else and look up their record. Once Found, select the sessions they are to attend.

Start Date:
Monday, April 20, 2020
End Date:
Wednesday, April 22, 2020
Address:
Arlington, VA 22209
UNITED STATES
AAMI Member
$0.00 - $765.00
List Price
$0.00 - $995.00


Medical Device Cybersecurity

A Guide for HTM Professionals
AAMI Member:
$160.00
List Price:
$239.00
Your Price:
$239.00
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Medical Device Cybersecurity (PDF)

A Guide for HTM Professionals
AAMI Member:
$160.00
List Price:
$239.00
Your Price:
$239.00
Available for Immediate Download
↑/↓ Full Details


Medical Device Integration and Informatics Compendium

Integration of medical devices with information systems
AAMI Member:
$0.00
List Price:
$0.00
Your Price:
$0.00
Available for Immediate Download
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Medical Device Risk Management and Safety Assurance Cases

The FDA recently reported that class I recalls have increased from an average of 25 per year before 2008 to 50 in 2011 and 57 in 2012 (1). A class I recall is a situation in which there is a reasonable probability that use, or exposure to, a medical device will cause serious adverse health consequences or death. As the complexity and sophistication of medical technology and health care infrastructure continue to increase, assuring proper identification and adequate risk controls of these potential recall situations (i.e. hazardous situations) prior to the device being placed on the market is becoming more and more critical and challenging. How effective are the existing medical device risk management practices in assuring proper identification and controls of risks? Are there any gaps and opportunities? How can these gaps be addressed? What is FDA’s view on this issue?
AAMI Member:
$119.00
List Price:
$199.00
Your Price:
$199.00
Available for Immediate Download
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Purchasing Controls and Supply Chain Management

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  • Industry experts will help you understand effective implementation of supplier selection and controls
  • Covers key aspects of supplier controls, from planning for supplier assessment/selection, to defining acceptance activities, to monitoring supplier performance
  • Each topic is presented from a practical perspective, with links to the requirements of the QSR, the ISO 13485 standard, risk management considerations and pertinent GHTF guidance

Registration Fees:

  • AAMI Members: $2160
  • Nonmembers: $2400
  • Government Employees: $860

Start Date:
Wednesday, June 03, 2020
End Date:
Friday, June 05, 2020
Time:
8:00 AM - 12:00 PM Eastern Daylight Time
Address:
AAMI Center for Excellence (ACE), 901 North Glebe
901 North Glebe Road Suite 300
Arlington, VA 22203
UNITED STATES
AAMI Member
$860.00 - $2,160.00
List Price
$860.00 - $2,400.00


Risk and Reliability in Healthcare and Nuclear Power: Learning from Each Other (PDF Format)

AAMI Member:
$35.00
List Price:
$60.00
Your Price:
$60.00
Available for Immediate Download
↑/↓ Full Details


Risk Management - November 2020

images/Events/901-Glebe.jpg
  • Understand risk management concepts used throughout the quality system to successful meet FDA, ANSI/AAMI/ISO 14971, and ANSI/AAMI/ISO 13485:2016 requirements
  • Learn how to use risk management to make risk-based decisions for product realization, from cradle to grave

Registration Fees:

  • AAMI Members: $2340
  • Nonmembers: $2600
  • Government Employees: $935

Start Date:
Tuesday, November 17, 2020
End Date:
Thursday, November 19, 2020
Time:
8:00 AM - 5:00 PM Eastern Standard Time
Address:
AAMI Center for Excellence (ACE)
901 North Glebe Road Suite 300
Arlington, VA 22203
UNITED STATES
AAMI Member
$935.00 - $2,600.00
List Price
$935.00 - $2,600.00


RTLS: Tracking Assets and Beyond

Real Time Location Systems have brought savings and efficiencies and are best known for tracking equipment and asset management. The systems now promote more efficient work and patient flow, enable nurse call and hand hygiene compliance, and monitor environmental conditions. As new applications are being developed, healthcare technology management (HTM) professionals play a key role in the assessment and selection of RTLS systems, and more departments and stakeholders looking to HTM to provide information and insights about the technologies.
AAMI Member:
$0.00
List Price:
$85.00
Your Price:
$85.00
Available for Immediate Download
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Selling HF: The Business Case for Human Factors in Industry

The purpose of this webinar is to share real-life experiences in “selling” Human Factors/Ergonomics (HF/E) to teams and to management that have not had HF/E experience in the past, or have an incorrect perception of what HF/E can offer.
AAMI Member:
$135.00
List Price:
$225.00
Your Price:
$225.00
Available for Immediate Download
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ST90: Quality Management Systems for Sterile Processing

This 90-minute webinar will show you how AAMI's new standard, ANSI/AAMI ST90, Processing of health care products—Quality management systems for reprocessing in health care facilities, provides the necessary framework for a quality management system for sterile processing departments.
AAMI Member:
$20.00
List Price:
$35.00
Your Price:
$35.00
Available for Immediate Download
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The Benefits of UDI for Healthcare Technology Management

This webinar addresses the benefits of Unique Device Identification (UDI), UDI requirements in the U.S., challenges healthcare facilities are facing with UDI implementation, and the overall impact to quality and quality systems for both manufacturers and healthcare facilities.
AAMI Member:
$0.00
List Price:
$85.00
Your Price:
$85.00
Available for Immediate Download
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The Quality System Compendium, 4th edition

CGMP Requirements and Industry Practice
AAMI Member:
$390.00
List Price:
$650.00
Your Price:
$650.00
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The Quality System Compendium, 4th edition (PDF)

CGMP Requirements and Industry Practice
AAMI Member:
$390.00
List Price:
$650.00
Your Price:
$650.00
Available for Immediate Download
↑/↓ Full Details


Writing an Effective Human Factors Engineering Procedure

This webinar discusses the need for medical device companies to create a human factors engineering (HFE) procedure that conforms to current HFE standards as well as the standards and expectations of the FDA and other regulators. Learn how an HFE procedure must be closely tied to a company’s risk management process (e.g., ISO 14971) and ways to turn a general procedure into a detailed and properly scaled one to guide a particular product development effort. This webinar serves the remedial benefit of explaining the purpose of the myriad HFE activities comprising a complete procedure. This webinar will enable audience members to immediately prepare appropriate procedures for their own organization.
AAMI Member:
$135.00
List Price:
$225.00
Your Price:
$225.00
Available for Immediate Download
↑/↓ Full Details