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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
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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
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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
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HTM Levels Guide - Second Edition (PDF)

A program-planning tool for healthcare technology management departments
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$0.00
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HTM Webinar Series: Bluetooth in the Healthcare Setting

Bluetooth® wireless technology (Bluetooth) is everywhere today, and is widely used in medical devices in hospital ranging from IT platforms to implanted devices. Bluetooth technology is also brought into the hospital with patients and their visitors in the form of smartphones, headsets, and gaming devices. This Webinar provides a high-level overview of the technology and key features of Bluetooth for Health Technology Management (HTM) professionals and technology professionals.
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HTM Webinar Series: Monthly Workload Tracker by Technician Using Data Modeling

Managers have a slew of reports and things to track from Preventive Maintenance, Corrective Maintenance, Incoming inspection, hazard alerts and projects. Often times, these reports are independent of one another and do not provide a comprehensive understanding of the time demands on each technician. As JC requirements have changed to 100% pm completion rate, a data model is required to assist management in ensuring that work assigned can feasibly be completed on time. This tool can be used to equitably redistribute workload among technicians while factoring in complexity and variances of work types.
AAMI Member:
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HTM Webinar Series: Part 1: Developing an HTM Specific Cybersecurity Framework

This is Part 1 of a 3 part webinar series. Medical device cybersecurity (application of processes/procedures, efforts, etc.) in healthcare technology management (HTM) is in its infancy. Many HTM professionals are unfamiliar with security and the framework necessary to incorporate good security practices into HTM service operations. Mayo Clinic has begun to bridge this divide by standing up an HTM Cybersecurity Team focused solely on developing a National Institute of Standards and Technology (NIST) based cybersecurity program. This webinar will provide insight into Mayo Clinic's approach and provide ideas on what to consider and how to develop an HTM Cybersecurity Program.
AAMI Member:
$0.00
List Price:
$0.00
Your Price:
$0.00
Available for Immediate Download
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HTM Webinar Series: Part 2 Developing an HTM Specific Cybersecurity Framework

This is Part 2 of a 3 part webinar series. Medical device cybersecurity (application of processes/procedures, efforts, etc.) in healthcare technology management (HTM) is in its infancy. Many HTM professionals are unfamiliar with security and the framework necessary to incorporate good security practices into HTM service operations. Mayo Clinic has begun to bridge this divide by standing up an HTM Cybersecurity Team focused solely on developing a National Institute of Standards and Technology (NIST) based cybersecurity program. This webinar will provide insight into Mayo Clinic's approach and provide ideas on what to consider and how to develop an HTM Cybersecurity Program.
AAMI Member:
$0.00
List Price:
$0.00
Your Price:
$0.00
Available for Immediate Download
↑/↓ Full Details


HTM Webinar Series: Part 3 Developing an HTM Specific Cybersecurity Framework

Medical device cybersecurity (application of processes/procedures, efforts, etc.) in healthcare technology management (HTM) is in its infancy. Many HTM professionals are unfamiliar with security and the framework necessary to incorporate good security practices into HTM service operations. Mayo Clinic has begun to bridge this divide by standing up an HTM Cybersecurity Team focused solely on developing a National Institute of Standards and Technology (NIST) based cybersecurity program. This webinar will provide insight into Mayo Clinic's approach and provide ideas on what to consider and how to develop an HTM Cybersecurity Program. This is Part 3 of a 3 Part webinar series.
AAMI Member:
$0.00
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$0.00
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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:
$68.00
List Price:
$113.00
Your Price:
$113.00
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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:
$68.00
List Price:
$113.00
Your Price:
$113.00
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Integrating Risk Management into the Product Life Cycle - November 2019

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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
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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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Medical Device Integration and Informatics Compendium

Integration of medical devices with information systems
AAMI Member:
$0.00
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$0.00
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$0.00
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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
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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
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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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