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ANSI/AAMI/IEC 80601-2-58:2014

Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal and vitrectomy devices for ophthalmic surgery
AAMI Member:
$90.00
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$157.00
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$157.00
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ANSI/AAMI/ISO 13022:2012

Medical products containing viable human cells -- Application of risk management and requirements for processing practices.
AAMI Member:
$133.00
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$236.00
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$236.00
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ANSI/AAMI/ISO 22442-1:2016 (PDF)

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management.
AAMI Member:
$96.00
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$168.00
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$168.00
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ANSI/AAMI/ISO 5840-1:2015

Cardiovascular implants-Cardiac valve prostheses-Part 1: General requirements
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$133.00
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$236.00
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$236.00
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ANSI/AAMI/ISO 5840-2:2015

Cardiovascular implants-Cardiac valve prostheses-Part 2: Surgically implanted heart valve substitutes
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$133.00
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$236.00
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$236.00
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ANSI/AAMI/ISO 5840-3:2013

Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques.
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$155.00
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$274.00
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$274.00
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ANSI/AAMI/UL 2800-1:2019

Standard for Safety for Medical Device Interoperability
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$240.00
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$402.00
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$402.00
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Checklists for Preventing Healthcare-Associated Infections

Key Considerations for the Purchase and Use of Reusable Medical Devices
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CHTM Study Guide

A resource for those preparing for the Certified Healthcare Technology Manager Examination
AAMI Member:
$62.00
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$96.00
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$96.00
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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
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$280.00
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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
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$280.00
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$280.00
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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


Medical Device Cybersecurity

A Guide for HTM Professionals
AAMI Member:
$155.00
List Price:
$232.00
Your Price:
$232.00
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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
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Premarket Risk Management

For New Medical Device Companies
AAMI Member:
$117.00
List Price:
$153.00
Your Price:
$153.00
Available for Immediate Download
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Preventing Medical Device Recalls

A critical and often overlooked aspect of preventing medical device recalls is the ability to implement systems thinking. Although systems thinking won’t prevent every mistake, it remains one of the most effective tools for evaluating hidden risks and discovering robust solutions for eliminating those risks.

Written by Dev Raheja, MS, CSP.
Published July 25, 2014 by CRC Press.
AAMI Member:
$79.00
List Price:
$108.00
Your Price:
$108.00
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Risk and Reliability in Healthcare and Nuclear Power: Learning from Each Other

AAMI Member:
$35.00
List Price:
$60.00
Your Price:
$60.00
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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
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The Quality System Compendium: CGMP Requirements and Industry Practice, Third Edition

Since the 2007 publication of the second edition, there have been substantial changes in medical device technology, medical device regulatory approaches, and FDA and international guidances and standards. This new third edition has been developed to provide accurate and useful information to the medical device community, updated to reflect the current status of the many rapidly evolving areas of the medical device environment.

AAMI Member:
$390.00
List Price:
$650.00
Your Price:
$650.00
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