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How to Do Benchmarking for Quality and Performance Managemen

This 60-minute webinar will help you get the most out of your computerized maintenance management system to effectively support your healthcare technology management department, with a focus on benchmarking for quality and performance management. You will learn about: qualitative measures, HTM Levels Guide, customer surveys, and quantitative measures.
AAMI Member:
$50.00
List Price:
$75.00
Your Price:
$75.00
Available for Immediate Download
↑/↓ Full Details


How to Manage Medical Device Integration, Cybersecurity, and Other HTM-IT Issues

This 60-minute webinar will help you get the most out of your computerized maintenance management system to effectively support your healthcare technology management department, with a focus on integration, cybersecurity, and other HTM-IT issues. You will learn about: tracking in CMMS for connectivity and security management, advanced CMMS applications, and CMMS interfaces with IT systems.
AAMI Member:
$50.00
List Price:
$75.00
Your Price:
$75.00
Available for Immediate Download
↑/↓ Full Details


How to Select and Implement a New CMMS Program

This 60-minute webinar will help you get the most out of your computerized maintenance management system to effectively support your healthcare technology management department, with a focus on selecting and implementing a new CMMS program. You will learn about: selection and implementation.
AAMI Member:
$50.00
List Price:
$75.00
Your Price:
$75.00
Available for Immediate Download
↑/↓ Full Details


How to Standardize CMMS Data and Maintain Data Integrity

This 60-minute webinar will help you get the most out of your computerized maintenance management system to effectively support your healthcare technology management department, with a focus on data integrity and standardization. You will learn about: CMMS basics, introduction to data integrity, standardizing data definitions, and how the CMMS can improve data integrity.
AAMI Member:
$50.00
List Price:
$75.00
Your Price:
$75.00
Available for Immediate Download
↑/↓ Full Details


How to Use CMMS Data Analytics to Support the AEM Program

This 60-minute webinar will help you get the most out of your computerized maintenance management system to effectively support your healthcare technology management department, with a focus on data analytics. You will learn about: benchmarking, Cost of Service Ratio (COSR), productivity, effective hourly rate, and staffing levels.
AAMI Member:
$50.00
List Price:
$75.00
Your Price:
$75.00
Available for Immediate Download
↑/↓ 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
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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 Lifecycle: Quality and 13485 - August 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 lifecycle 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 lifecycle, 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 lifecycle. In addition, interactive, hands on exercises will allow participants to practice applying risk management concepts, principles, and tools throughout the product lifecycle 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 IMDR 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 Lifecycle: Quality and 13485 - March 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 lifecycle 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 lifecycle, 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 lifecycle. In addition, interactive, hands on exercises will allow participants to practice applying risk management concepts, principles, and tools throughout the product lifecycle 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 IMDR 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, March 12, 2019
End Date:
Thursday, March 14, 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 Lifecycle: Quality and 13485 - 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 lifecycle 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 lifecycle, 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 lifecycle. In addition, interactive, hands on exercises will allow participants to practice applying risk management concepts, principles, and tools throughout the product lifecycle 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 IMDR 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


IT Horizons 2008 Edition

The 4th edition of IT Horizons, published in December 2008, features articles on such issues as the convergence of biomedical and information technologies, the new IEC/ISO 80001 standard (Application of risk management for IT networks incorporating medical devices), and the latest on interoperability of medical devices and systems.
AAMI Member:
$22.00
List Price:
$36.00
Your Price:
$36.00
↑/↓ Full Details


Know When To Hold 'Em - Use Your Poker Skills in Management

Know When To Hold 'Em - Putting Your Poker Skills to Use in Management
AAMI Member:
$17.00
List Price:
$29.00
Your Price:
$29.00
Available for Immediate Download
↑/↓ Full Details


Leading Practice-Quality Mngmnt: Effective Training Prgms

This Leading Practice document is designed to help medical device firms better understand, implement, and comply with the training section of the Quality System Regulation 21 CFR 820.25(a) (b) as well as ISO 13485:2003 Section 6.2.2.
AAMI Member:
$40.00
List Price:
$68.00
Your Price:
$68.00
Available for Immediate Download
↑/↓ Full Details


Leading Practices - Management Responsibility

Leading Practices - Management Responsibility
AAMI Member:
$40.00
List Price:
$68.00
Your Price:
$68.00
Available for Immediate Download
↑/↓ Full Details


Medical Device Cybersecurity

A Guide for HTM Professionals
AAMI Member:
$155.00
List Price:
$232.00
Your Price:
$232.00
↑/↓ Full Details


Medical Device Cybersecurity (PDF)

A Guide for HTM Professionals
AAMI Member:
$155.00
List Price:
$232.00
Your Price:
$232.00
Available for Immediate Download
↑/↓ Full Details