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A Comprehensive Overview of the Current FDA Guidances and International Standards for Medical Device Software (Webinar On Demand)

With the extensive and rapidly evolving use of software in today’s medical devices, it is important for industry professionals to understand the implications of regulatory requirements for medical device software and to be aware of the many guidances and standards that are available to industry on this important topic.
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$119.00
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$199.00
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A Guide for Medical Device Manufacturers: Understanding and Applying the FDA Processes, Terminology, and Informational Databases for U.S. Medical Device Classification (Webinar On Demand)

This webinar provides a comprehensive overview of the FDA processes, terminology, and informational databases established for U.S. medical device classification.
AAMI Member:
$119.00
List Price:
$199.00
Available for Immediate Download
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AAMI 2016 Annual Conference Archive - All Sessions

Even if you couldn't make it to AAMI 2016 in Tampa, you don't have to miss all of the great education opportunities that took place.
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$299.00
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$499.00
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AAMI TIR43:2011 — Ultrapure dialysate for hemodialysis and related therapies (Webinar On Demand)

ANSI/AAMI/ISO 23500:2011, Guidance for the preparation and quality management of fluids for hemodialysis and related therapies makes a recommendation that ultrapure dialysate should be used for routine hemodialysis. This is not currently the standard of practice in the U.S. The objective of AAMI TIR43:2011, Ultrapure dialysate for hemodialysis and related therapies is to provide dialysis clinics with background information to understand the rationale for the inclusion in ANSI/AAMI/ISO 23500 of this recommendation and useful strategies for implementing practices to allow provision of ultrapure dialysate.
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$15.00
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$20.00
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AAMI TIR45:2012, Guidance on the use of AGILE practices in the development of medical device software (Webinar On Demand)

This webinar archive provides detailed information about AAMI TIR45:2012, Guidance on the use of AGILE practices in the development of medical device software and its recommendations for complying with international standards and FDA guidance documents when using AGILE practices to develop medical device software.
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$119.00
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$199.00
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AAMI TIR57: Principles for Medical Device Security--Risk Management (Webinar On Demand)

This webinar, led by the co-chairs of the committee who developed TIR57, outlines the document and its application to your business. TIR57 provides guidance for addressing information security within the risk management framework defined by ANSI/AAMI/ISO 14971.
AAMI Member:
$119.00
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$199.00
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Alarms Part I: The Joint Commission’s National Patient Safety Goal on Alarm Management: How Do We Get Started? (Webinar On Demand)

Clinical alarms are a high-frequency, high-risk patient safety hazard for all hospitals. This is the first of a series of seven webinars on alarms. By the end of the series, healthcare delivery organization alarm management teams will be prepared to comply with The Joint Commission’s (TJC) new National Patient Safety Goal (NPSG) on Alarm Management. This first webinar will set the stage for the series and outline the complexity of issues related to alarm systems and the events that have led to the spotlight on alarm systems and alarm fatigue. It will cover the overall scope of TJC's NPSG, the timeline for meeting the requirements, and how the series will help the participant start to meet the NPSG.
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Alarms Part II: How to Identify the Most Important Alarm Signals to Manage (Webinar On Demand)

This on demand webinar will help the participant to use alarm system data to identify their highest priority alarm conditions and corresponding signals.
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Alarms Part III: How to Manage Alarms at the Bedside (Webinar On Demand)

This webinar will help the participant address the practical issues of managing alarms at the bedside. This session will help you answer the following questions: How do you get input from the medical staff and clinical departments? When can alarm signals be disabled? Who can disable them? When can alarm parameters be changed? Who can change them? What is the best way to monitor and respond to alarm signals? How do you check individual alarm signals for accuracy?
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Alarms Part IV: Use of Middleware in Alarm Management: Ancillary Notification and Obtaining Alarm Data (Webinar On Demand)

This streaming webinar archive will address the use of middleware as an ancillary alarm notification system and as a tool to collect alarm data. This webinar will cover: definition of middleware and how it works; overview of ancillary alarm notification systems including: necessary components for implementation, use of these systems for alarm integration of multiple devices, and process for sending alarms to communication device; human factors considerations; how to use middleware to acquire alarm data; how to determine the best ancillary alarm notification approach for your organization, including selection of wireless communication device; and a case study on use of an ancillary alarm notification system for alarm integration of monitor, ventilator, bed exit, and nurse call system alarms.
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Alarms Part V: Best Practices in Alarm Systems Management: Kaiser Permanente, Children's National Medical Center, and Johns Hopkins Hospital (Webinar On Demand)

This streaming webinar archive will highlight experiences from Kaiser Permanente, Children's National Medical Center, and Johns Hopkins Hospital. These hospitals will share their experiences with getting data, taking patients off monitors, and forming governance groups.
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Alarms Part VI: Current Challenges with Ventilator Alarms (Webinar On Demand)

This webinar addresses the current state of and current challenges for ventilator alarm management. The objectives of the webinar are to: identify the problems associated with ventilator alarm safety; discuss the industry perspective, including standards and alarm hierarchy; evaluate a current quality improvement process for ventilator alarm safety; identify limitations with and barriers to responding appropriately to ventilator alarms; and consider recommendations on managing alarms at the bedside.
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Alarms Part VII: Educating and Training Your Staff: Circling Back to Your Policies and Procedures (Webinar On Demand)

This streaming webinar archive will address the importance of educating and training staff on alarm system management and the tools that hospitals will need to continue to meet The Joint Commission's patient safety goal. This session will also address ways and the importance of establishing and maintaining a comprehensive database of alarmed equipment. This webinar will also review the patient safety goal in terms of what was covered during the webinar series.
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An FMEA Trifecta: sFMEA, dFMEA, & pFMEA (Webinar On Demand)

If you perform a System-Level Failure Mode & Effects Analysis (sFMEA), a Design FMEA (dFMEA), and a Process FMEA (pFMEA), then they can be linked to become a robust risk-analysis tool set. Linking these three tools can be considered a trifecta* • a safe bet on risk mitigation. A successful trifecta is great cause for celebration • risk and product managers can finally rest easy!
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$119.00
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$199.00
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An Overview of ANSI/AAMI/ISO 14155:2011: Clinical Investigation of Medical Devices for Human Subjects

Clinical studies are included in almost all new devices presented for premarket approval (PMA) to the U.S. Food and Drug Administration (FDA) and may also apply to the approximately 10% of devices under premarket notification that contain clinical data. ANSI/AAMI/ISO 14155:2011, Clinical investigation of medical devices for human subjects addresses the practical aspects of how to plan clinical investigations conducted in human subjects and defines procedures for the design, conduct, recording, and reporting of a clinical study. The latest version of the standard has been updated to provide step-by-step guidance on the creation and execution of a clinical study. This webinar will address good clinical practice in clinical investigations of medical devices for human subjects using ISO 14155 as a guide.
AAMI Member:
$149.00
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$249.00
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ANSI/AAMI ST91:2015: Flexible and Semi-Rigid Endoscope Processing in Health Care Facilities - What You Need to Know (Webinar On Demand)

With heightened public concern about cleanliness and decontamination, endoscopes and endoscope reprocessing are in the news seemingly every day. Reducing the risk of exposure to improperly reprocessed medical devices is a shared responsibility among the healthcare facilities responsible for cleaning, sterilizing, or disinfecting the devices.
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$20.00
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$35.00
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ANSI/AAMI/IEC 80001-1 • Sharing the Burden: Collaborating to Keep Networks Safe, Secure, and Effective

This webinar archive addresses the requirements for collaboration in 80001-1, how they should be implemented, how to voluntarily get the cooperation that is needed, and what cooperation will look like.
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$85.00
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ANSI/AAMI/IEC 80001-1 • Successfully Launching an 80001-1-Based Program

ANSI/AAMI/IEC 80001-1:2010, Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities introduces a new framework for managing safety and security when medical devices are included on a convergent, heterogeneous IT-network. This approach not only identifies the activities necessary to maintain key properties of the network (safety, effectiveness, and security), it also identifies the roles that are needed and the collaboration necessary between a healthcare delivery organization and its networked technology suppliers.
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$85.00
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Applying Human Factors Engineering to Legacy Medical Devices (Webinar On Demand)

ANSI/AAMI/IEC 62366 calls for manufacturers to implement a rigorous HFE program in conjunction with developing medical devices for which they will seek regulatory approval; an approval that hinges on compliance with IEC standards. However, most legacy medical devices were not developed with a focus on HFE. Consequently, manufacturers are struggling to understand how much HFE is enough when reassessing the use-safety of legacy devices that they have little interest in modifying based on retrospective HFE analyses.
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$135.00
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$225.00
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Applying Novel Sterilization Processes to Healthcare Products

This webinar will explain the process for introducing a novel sterilization process to a healthcare product and will identify the regulatory hurdles that must be met. Attendees will learn how to define, validate, and ultimately routinely control a novel sterilization process such as vaporized peracetic acid; high intensity, pulse, or UV light, microwave radiation or sound waves; or nitrogen dioxide.
AAMI Member:
$149.00
List Price:
$249.00
Available for Immediate Download
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