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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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Medical Device Symbols from ANSI/AAMI/ISO 15223-1:2016

AAMI Member:
$479.00
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$690.00
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$690.00
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One Man's Century with Pen, Brush, Fiddle and Scalpel

One Man's Century with Pen, Brush, Fiddle and Scalpel

Harold Laufman, MD, PhD, a renowned surgeon, provides an insightful accounting of a 10-decade journey through life. His story is unique in that it is actually a tale of an exceptional man's five lives and three professions - plus a number of ancedotal highlights ranging from how his parents recognized and responded to the outlandish needs of a gifted child to how he almost killed Jascha Heifetz. The author's five lives were a personal life, a life in art, a life in music, a life in clinical surgery and surgical research, including a stint as a front-man surgeon in World War II, and a post surgical life as a bioengineer.

Laufman, who served as AAMI’s president in the mid-1970s, passed away at the age of 98 in 2010. But his unique long life lives on in this special book.
AAMI Member:
$57.00
List Price:
$85.00
Your Price:
$85.00
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Personnel Safety in Sterile Processing Departments Video

This 60-minute instructional video provides information essential to the promotion of personnel safety in sterile processing departments.

Earn 1 credit hour CE through CBSPD and IAHCSMM.

The script was written by P. Richard Warburton, PhD, JD; CTO & General Counsel, ChemDAQ, Inc. It includes practical guidance on:
- Legal duties and who's who among the relevant regulatory agencies and professional organizations
- Common hazards encountered in the sterile processing department
- Bloodborne pathogens and infection prevention
- Proper selection, use, and disposal of personal protective equipment (PPE)
- Relevant standards that pertain to the use of PPE, steam and chemical sterilization, and ethylene oxide
- Safe storage, handling, and disposal of contaminated items and chemical agents
- Key elements of engineering controls that promote safe handling of sterilants and high-level disinfectants
- Appropriate labelling of chemicals
- Responsibilities of employers and staff in preventing, managing, and reporting accidents in the workplace
AAMI Member:
$132.00
List Price:
$220.00
Your Price:
$220.00
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Process Validation Requirements and Industry Practice-April 2019

images/Events/901-Glebe.jpg
Description: This 2.5-day course provides attendees with practical tools and techniques for process validation requirements for FDA’s Quality System regulation and recognized Process Validation Guidance from the Global Harmonization Task Force. The program includes industry best practices and real-life process validation examples. Demonstrate Return on Investment (ROI) to employers by completing and passing the Process Validation Post-Course Test. This optional, one-hour, self-assessment tests your mastery of the course materials and your ability to correctly interpret the Quality System regulation. This optional post-test which is available online for 2 weeks following the end of the program, will be available to all participants.

 Registration Fees:

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

 

 

Program Outline

 


DAY 1 | 8 AM-5 PM
Intro to Process Validation Requirements & Their Relationship to Design Controls
Master Validation Planning
Installation Qualification & Software Validation 

Operational Qualification


DAY 2 | 8 AM-5 PM
Operational Qualification Continued
Performance Qualification
Implementation & Documentation


DAY 3 | 8 AM-12 PM
Monitoring & Control 
Revalidation
Advanced Planning & Validation Strategies 






 

 

Program Objective

Upon completion of this course, participants will be able to: determine which processes require validation and develop a Master Validation Plan; develop protocol content to ensure a successful validation; document the results and the resolution of deviations that occur during validation; plan for effective monitors and controls for the validated processes; and determine the revalidation requirements for product and process changes.

 

Target Audience

Instruction is geared to professionals involved with process validation in the medical device industry such as R&D Team Members, Quality Engineers, Quality Assurance Managers, Design Engineers, Project/Program Managers, and Process Engineers. To maximize the peer learning opportunity, AAMI recommends this course for those who already have a basic understanding of the Quality System regulation and have some relevant work experience.

 

Format

This 2.5-day program provides intensive coverage of process validation and includes a variety of real-life examples, case studies, and exercises that cover process validation activities. These exercises provide participants with the opportunity to apply new information to actual validation scenarios. The course includes a general description of statistical methods and tools as they relate to process validation.

 

Materials

Fee includes a printed copy of the textbook, The Quality System Compendium, and electronic versions of the PowerPoint presentations and case studies, pertinent FDA documents, additional references, and access to the online exam.


Start Date:
Tuesday, April 16, 2019
End Date:
Thursday, April 18, 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 - $2,135.00
List Price
$950.00 - $2,435.00


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.
AAMI Member:
$0.00
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$0.00
Your Price:
$0.00
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Reliable Design of Medical Devices

Now in its Third Edition, this bestselling book shows you how to improve reliability in the design of advanced medical devices. Mirroring the typical product development process, the book provides an introduction to the basics of reliability engineering and failures, and then it takes you through the concept, feasibility, design, verification and validation, design transfer and manufacturing, and field activity phases.
AAMI Member:
$164.00
List Price:
$220.00
Your Price:
$220.00
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Sterile Processing: Knowledge, Skills, Competencies

Designed for both technicians and managers, Sterile Processing-Knowledge, Skills, Competencies is organized into modules that describe the key terms and principles critical to sterile processing. This resource provides new (and maybe not-so-new) employees with the evidence needed to make the right decision every time they face a question about instrument processing.
AAMI Member:
$111.00
List Price:
$164.00
Your Price:
$164.00
Available for Immediate Download
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