0 item(s) ($0.00)
Product Categories
Search Results
Showing 41 - 60 of 80 Results
Sort by

CHTM Study Guide

A resource for those preparing for the Certified Healthcare Technology Manager Examination
AAMI Member:
$62.00
List Price:
$96.00
Your Price:
$96.00
↑/↓ Full Details


Computerized Maintenance Management Systems

AAMI Member:
$95.00
List Price:
$137.00
Your Price:
$137.00
↑/↓ Full Details


Core Competencies for the HTM Entry-level Tech

A Guide for Curriculum Development in Academic Institutions
AAMI Member:
$0.00 - $45.00
List Price:
$0.00 - $75.00
Your Price:
$0.00 - $75.00
↑/↓ Full Details


Emergency Management in Health Care: An All-Hazards Approach

Updated and expanded in 2012, the second edition of this book leads healthcare organization through all aspects of emergency management planning.

Published 2012 by the Joint Commission Resources, Inc. - 202 pages.
AAMI Member:
$85.00
List Price:
$113.00
Your Price:
$113.00
↑/↓ Full Details


Flexible Solutions for Device Supportability

This Leading Practice document discusses the concept of medical device "supportability," which encompasses product design, product support, and other company procedures that impact the management of healthcare technology. The document offers practical tips and guidance to help Healthcare Technology Management (HTM) professionals and device manufacturers work toward mutually beneficial relationships and results.
AAMI Member:
$40.00
List Price:
$68.00
Your Price:
$68.00
Available for Immediate Download
↑/↓ Full Details


Getting Started with IEC 80001 & 80001-1 Standard

Includes Getting Started with IEC 80001 handbook and ANSI/AAMI/IEC 80001-1, Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities.
AAMI Member:
$168.00
List Price:
$280.00
Your Price:
$280.00
↑/↓ Full Details


Getting Started with IEC 80001 & 80001-1 Standard (PDF)

Includes Getting Started with IEC 80001 handbook and ANSI/AAMI/IEC 80001-1, Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities. (PDF format)
AAMI Member:
$168.00
List Price:
$280.00
Your Price:
$280.00
Available for Immediate Download
↑/↓ Full Details


Healthcare Technology Horizons

This publication focuses on issues of mutual interest to engineers, technicians, and nurses. Articles include clinical alarms management, RFID, wireless solutions, troubleshooting, communications, robot-assisted technology, collaborative investigations, and more.
AAMI Member:
$22.00
List Price:
$36.00
Your Price:
$36.00
↑/↓ Full Details


Horizons 2010 Fall: Human Factors Horizons

Human factors engineering is concerned with understanding the interactions among humans and other elements of a system. How can the principles of human factors be used to improve the design, use, and management of medical devices? How can we reduce medical errors and increase patient safety by improving the interface between healthcare practitioners and medical technology?
AAMI Member:
$22.00
List Price:
$36.00
Your Price:
$36.00
↑/↓ Full Details


Horizons 2013 Spring: Home Healthcare

Home Healthcare: Tackling the Challenge of Medical Technology in Nonclinical Settings

The explosive growth of home healthcare means that medical devices increasingly are being used away from controlled, acute-care environments. What special challenges need to be considered with the design, maintenance, and management of home healthcare devices?
AAMI Member:
$22.00
List Price:
$36.00
Your Price:
$36.00
↑/↓ Full Details


Horizons 2015 Spring: Risk

RISK - How Do You Manage It Effectively?

AAMI Member:
$22.00
List Price:
$36.00
Your Price:
$36.00
↑/↓ Full Details


Horizons 2017 Spring: Clinical Alarms

Managing the Overload

Including:
- Factors that Affect Design of Secondary Alam Notification Systems
-Alarm Management Lessons from the Process Industries
-Reduction of Nonactionable Alarms in Medical Intensive Care
AAMI Member:
$22.00
List Price:
$36.00
Your Price:
$36.00
↑/↓ Full Details


HTM Levels Guide - Second Edition (PDF)

A program-planning tool for healthcare technology management departments
AAMI Member:
$0.00
List Price:
$0.00
Your Price:
$0.00
Available for Immediate Download
↑/↓ Full Details


Human Factors and Ergonomics in Health Care & Patient Safety

Human Factors and Ergonomics in Health Care and Patient Safety, 2nd Edition

The 2nd edition of this book is the ultimate compendium of human factors and ergonomics issues relevant to healthcare and patient safety. It provides a practical approach with coverage of methods, interventions, and applications. Topics include work schedules, error recovery, telemedicine, workflow analysis, simulation, health IT development and design, and patient safety management. 876 pages.
AAMI Member:
$142.00
List Price:
$203.00
Your Price:
$203.00
↑/↓ Full Details


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:
$68.00
List Price:
$113.00
Your Price:
$113.00
↑/↓ Full Details


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:
$68.00
List Price:
$113.00
Your Price:
$113.00
Available for Immediate Download
↑/↓ Full Details


Integrating Risk Management into the Product Life Cycle - July 2019

http://my.aami.org/aamiresources/images/events/901-Glebe.jpg

This comprehensive 3-day course for medical device manufacturers presents risk management concepts used throughout the quality system that can help your organization meet FDA and ANSI/AAMI/ISO 13485:2016 requirements for risk management. This course covers the use of risk management principles throughout the life cycle of the product, from design…to manufacturing…through post-production to retirement. Instructors will illustrate linkages between the product risk management process and quality system processes.Students will discover how to use regulatory databases to support risk management activities at different stages of the product life cycle, as well as the use of International Product Safety Standards during risk management activities.

Registration Fees:

  • AAMI Members: $2335
  • Nonmembers: $2635
  • Government Employees: $950

 

 

Program Outline

 


DAY 1 | 8 AM-5 PM 

Introduction to ISO 14971

Basic Terms and Concepts

Risk Management requirements

Management Responsibilities

Risk Management at CDRH



DAY 2 | 8 AM-5 PM 

Risk Management in Product realization

· Design Controls

· Risk Management and Usability

· Production and Service provision

· Control of Monitoring and Measuring equipment

Special requirements for Software Risk Management



DAY 3 | 8 AM-5 PM 
Overall Residual Risk

 

Production and Post-Production Information including Medical MDR and IVDR requirements

Managing the risk management file

 

Risk Management in quality systems than Product realization









 

 

Program Objective

FDA and AAMI faculty work together to help the learner understand:

 

· Basic terms of risk management and how they relate to each other and how to use risk management throughout the quality system to make risk-based decisions for product realization cradle to grave

· How to use a variety of risk management tools to support risk-based thinking and decision making along with typical scenarios when the tools can be most useful,

· FDA's expectations for submissions and compliance, as well as how to apply risk management principles to various aspects of a quality system as required by the FDA and ISO 13485:2016,

· The current state of risk management based on ISO 14971 and other applicable product safety standards including those related to processes and those related to specific medical device products.

· How risk management is audited during MDSAP audits and how that relates to country specific requirements for risk management activities or risk-based decisions.

Target Audience

Instruction is targeted to quality assurance and regulatory affairs personnel, design and process engineers, manufacturing and operations managers, and members of research and development or new product development teams. For participants to gain the maximum benefit from this course, it is recommended for those who have a working knowledge of the Quality System regulation and design controls or who have already attended AAMI's Quality System and Design Control courses.

 

Format

Learning objectives are delivered in a highly interactive format includes relevant examples from a broad product spectrum that demonstrate current industry practices of risk management throughout the quality system and product life cycle. In addition, interactive, hands on exercises will allow participants to practice applying risk management concepts, principles, and tools throughout the product life cycle and the quality system.

 

Materials

Fee includes a comprehensive eNotebook of all training materials and many of the referenced materials, including FDA and Global Harmonization Task Force, and IMDRF guidance documents relevant to the course, all in one easy to find and download location. Also provided is ANSI/AAMI/ISO 14971:2007/(R) 2010, Medical devices - Application of risk management to medical devices



Start Date:
Tuesday, July 30, 2019
End Date:
Thursday, August 01, 2019
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
$950.00 - $2,335.00
List Price
$950.00 - $2,635.00


Integrating Risk Management into the Product Life Cycle - November 2019

http://my.aami.org/aamiresources/images/events/901-Glebe.jpg

This comprehensive 3-day course for medical device manufacturers presents risk management concepts used throughout the quality system that can help your organization meet FDA and ANSI/AAMI/ISO 13485:2016 requirements for risk management. This course covers the use of risk management principles throughout the life cycle of the product, from design…to manufacturing…through post-production to retirement. Instructors will illustrate linkages between the product risk management process and quality system processes. Students will discover how to use regulatory databases to support risk management activities at different stages of the product life cycle, as well as the use of International Product Safety Standards during risk management activities.

Registration Fees:

  • AAMI Members: $2335
  • Nonmembers: $2635
  • Government Employees: $950

 

 

Program Outline

 


DAY 1 | 8 AM-5 PM 

Introduction to ISO 14971

Basic Terms and Concepts

Risk Management requirements

Management Responsibilities

Risk Management at CDRH



DAY 2 | 8 AM-5 PM 

Risk Management in Product realization

· Design Controls

· Risk Management and Usability

· Production and Service provision

· Control of Monitoring and Measuring equipment

Special requirements for Software Risk Management



DAY 3 | 8 AM-5 PM 
Overall Residual Risk

 

Production and Post-Production Information including Medical MDR and IVDR requirements

Managing the risk management file

 

Risk Management in quality systems than Product realization









 

 

Program Objective

FDA and AAMI faculty work together to help the learner understand:

 

· Basic terms of risk management and how they relate to each other and how to use risk management throughout the quality system to make risk-based decisions for product realization cradle to grave

· How to use a variety of risk management tools to support risk-based thinking and decision making along with typical scenarios when the tools can be most useful,

· FDA's expectations for submissions and compliance, as well as how to apply risk management principles to various aspects of a quality system as required by the FDA and ISO 13485:2016,

· The current state of risk management based on ISO 14971 and other applicable product safety standards including those related to processes and those related to specific medical device products.

· How risk management is audited during MDSAP audits and how that relates to country specific requirements for risk management activities or risk-based decisions.

Target Audience

Instruction is targeted to quality assurance and regulatory affairs personnel, design and process engineers, manufacturing and operations managers, and members of research and development or new product development teams. For participants to gain the maximum benefit from this course, it is recommended for those who have a working knowledge of the Quality System regulation and design controls or who have already attended AAMI's Quality System and Design Control courses.

 

Format

Learning objectives are delivered in a highly interactive format includes relevant examples from a broad product spectrum that demonstrate current industry practices of risk management throughout the quality system and product life cycle. In addition, interactive, hands on exercises will allow participants to practice applying risk management concepts, principles, and tools throughout the product life cycle and the quality system.

 

Materials

Fee includes a comprehensive eNotebook of all training materials and many of the referenced materials, including FDA and Global Harmonization Task Force, and IMDRF guidance documents relevant to the course, all in one easy to find and download location. Also provided is ANSI/AAMI/ISO 14971:2007/(R) 2010, Medical devices - Application of risk management to medical devices



Start Date:
Wednesday, November 13, 2019
End Date:
Friday, November 15, 2019
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
$950.00 - $2,335.00
List Price
$950.00 - $2,635.00


ISO 13485:2016 Handbook (PDF)

Medical Devices - A Practical Guide. Advice from ISO/TC 210
AAMI Member:
$96.00
List Price:
$134.00
Your Price:
$134.00
Available for Immediate Download
↑/↓ Full Details


IT Baseline Knowledge for the Healthcare Technology Management Professional

Prepare yourself for a two-part webinar series covering the basic operations of essential network devices and protocols. These sessions will cover a wide IT network landscape, creating a foundation of networking knowledge for the service engineer working in healthcare. Topics are covered at a suitable technical level to gain an understanding of the use and fit of networking devices and protocols with a special focus on aspects related to healthcare.
AAMI Member:
$0.00
List Price:
$85.00
Your Price:
$85.00
Available for Immediate Download
↑/↓ Full Details