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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
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$36.00
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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
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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
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$68.00
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$68.00
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Leading Practices - Management Responsibility

Leading Practices - Management Responsibility
AAMI Member:
$40.00
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$68.00
Your Price:
$68.00
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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
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Patient Safety Seminar - May 20, 2016

What system, structural, and technological changes are necessary to capture real-time, critical data of early deterioration in adult postoperative inpatients, to prevent failure to rescue?

Does Continuous Vital sign Monitoring Detect Early Deterioration of Patients Receiving Parenteral Opioids?

Obtain a nursing Continuing Education credit.

This online seminar presents the work from Johns Hopkins Hospital about its improvements in the area of continuously monitoring patients on parenteral opioids in the general care setting.


AAMI Member:
$25.00
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$25.00
Your Price:
$25.00
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Premarket Risk Management

For New Medical Device Companies
AAMI Member:
$117.00
List Price:
$153.00
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$153.00
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Purchase CE for Seminar - August 8, 2016

Raising the Bar on Infusion Safety: Patient Safety Initiatives at Western Maryland Health System and Cameron Memorial Community Hospital

Learn how two hospitals approached the challenges in improving compliance with the use of their smart-pump drug libraries.

Speakers:
Christine Ruhl, BSN. MBA, CCRN Director, Critical Care Services Western Maryland Health System
Cumberland, MD

Andrew Aldred, PharmD, MBA Director of Pharmacy and Materials Management Cameron Memorial Community Hospital
Angola, IN
AAMI Member:
$25.00
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$25.00
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$25.00
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Purchasing Controls & Supply Chain Management-June 2019

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This 2½ day course provides extensive information on effective implementation of supplier selection and controls. This detailed course covers the 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 Quality System regulation, the ISO 13485 standard, risk management considerations, and pertinent Global Harmonization Task Force guidance.

The course also covers life-cycle management approaches for a medical device manufacturing organization’s supply chain. The course includes substantial “hands-on” exercises to allow attendees to apply concepts and interact with colleagues, and provides specific industry examples.

Registration Fees:

  • AAMI Members: $2135
  • Nonmembers: $2435
  • Government Employees: $950

 

 

Program Outline

 


DAY 1 | 8 AM-5 PM

Definitions and Regulatory Requirements

Planning

Supplier Selection



DAY 2 | 8 AM-5 PM

Supplier Selection Continued

Defining Supplier Controls

Day-to-Day Operations

Communications and Improvements



DAY 3 | 8 AM-12 PM

Integrating Supplier Controls Throughout the Quality Management Systems

Supply Chain Management

Submissions and Compliance






 

 

Program Objective

Upon completing this course participants will be able to evaluate their organization's compliance with FDA's requirements for purchasing controls and acceptance activities, and consider appropriate risk mitigation strategies for supplied products and services.

 

Target Audience

This course is targeted to professionals involved in establishing supplier agreements, supplier quality management, purchasing activities, Quality System compliance, and regulatory submissions for significantly outsourced products.

 

Format

A combination of situation analyses, case study exercises, and both formal and informal discussions are used throughout the program to provide maximum opportunity for the application of information.

 

Materials

Fee includes electronic versions of the PowerPoint presentations and case studies, pertinent FDA documents and additional references. td>

Start Date:
Wednesday, June 19, 2019
End Date:
Friday, June 21, 2019
Time:
8:00 AM - 12:00 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 - $2,135.00
List Price
$950.00 - $2,435.00


Recorded Webinar - 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
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$0.00
Your Price:
$0.00
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Recorded Webinar 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
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$0.00
Your Price:
$0.00
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Recorded Webinar: 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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$0.00
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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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Spring 2014 Horizons: Cybersecurity in Healthcare: What You Need to Know

AAMI Member:
$22.00
List Price:
$36.00
Your Price:
$36.00
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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
This item is on backorder.
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WEBINAR: Monthly Workload Tracker by Technician Using Data Modeling

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Description: Managers have a slew of reports and things to track from Preventative 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.
NOTE: In registering for this webinar, attendees give AAMI the right to share email contact information with the sponsor of this event.

Date:
Tuesday, July 16, 2019
Time:
3:00 PM - 4:00 PM Eastern Daylight Time
Speakers:
Arleen Thukral, MSBME CHTM
VISN 20 Biomedical Engineer
VA Puget Sound Health Care System

AAMI Member
$0.00
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$0.00


WEBINAR: Part 3 - Developing an HTM Specific Cybersecurity Framework

Generic Event Image
Description: 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 series.
NOTE: In registering for this webinar, attendees give AAMI the right to share email contact information with the sponsor of this event.

Date:
Tuesday, April 16, 2019
Time:
2:00 PM - 3:00 PM Eastern Daylight Time
AAMI Member
$0.00
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$0.00