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Integrating Risk Management into the Product Life Cycle

https://my.aami.org/store/images/events/webinar.jpg
  • Understand risk management concepts used throughout the quality system to successful meet FDA, ANSI/AAMI/ISO 14971, and ANSI/AAMI/ISO 13485:2016 requirements
  • Learn how to use risk management to make risk-based decisions for product realization, from cradle to grave

Registration Fees:

  • AAMI Members: $2340
  • Nonmembers: $2600
  • Government Employees: $935
Tuesday, August 18, 2020
Thursday, August 20, 2020
8:00 AM - 5:00 PM Eastern Daylight Time
Virtual Attendance Only
Virtual Attendance Only
$935.00 - $2,340.00
$935.00 - $2,600.00


Integrating Risk Management into the Product Life Cycle

https://imis.aami.org/AAMI/images/Events/webinar-image.jpg
  • Understand risk management concepts used throughout the quality system to successful meet FDA, ANSI/AAMI/ISO 14971, and ANSI/AAMI/ISO 13485:2016 requirements
  • Learn how to use risk management to make risk-based decisions for product realization, from cradle to grave

Registration Fees:

  • AAMI Members: $2340
  • Nonmembers: $2600
This course will be offered virtually only on Western European time. 8am-5pm Western EU time = 3am-12pm Eastern standard time.

(All registration fees are to be made payable in U.S. Dollars, payments submitted via check must be drawn on a U.S. Bank)
Monday, October 12, 2020
Wednesday, October 14, 2020
3:00 AM - 12:00 PM Eastern Daylight Time
Virtual Attendance Only
Virtual Attendance Only
$2,340.00
$2,600.00


Integrating Risk Management into the Product Life Cycle

https://my.aami.org/aamiresources/images/Events/901-Glebe.jpg
  • Understand risk management concepts used throughout the quality system to successful meet FDA, ANSI/AAMI/ISO 14971, and ANSI/AAMI/ISO 13485:2016 requirements
  • Learn how to use risk management to make risk-based decisions for product realization, from cradle to grave

Registration Fees:

  • AAMI Members: $2340
  • Nonmembers: $2600
  • Government Employees: $935
Tuesday, November 17, 2020
Thursday, November 19, 2020
8:00 AM - 5:00 PM Eastern Standard Time
AAMI Center for Excellence (ACE)
901 North Glebe Road Suite 300
Arlington, VA 22203
UNITED STATES
$935.00 - $2,340.00
$935.00 - $2,600.00


Medical Device Cybersecurity

A Guide for HTM Professionals
$160.00
$239.00
$239.00

Medical Device Cybersecurity (PDF)

A Guide for HTM Professionals
$160.00
$239.00
$239.00
Available for Immediate Download

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?
$119.00
$199.00
$199.00
Available for Immediate Download

Risk and Reliability in Healthcare and Nuclear Power: Learning from Each Other (PDF Format)

$35.00
$60.00
$60.00
Available for Immediate Download

The Quality System Compendium, 4th edition (PDF)

CGMP Requirements and Industry Practice
$390.00
$650.00
$650.00
Available for Immediate Download

Validation of a Medical Device Cleaning Process

There is increased focus by regulators around the world on medical device cleaning processes, and many medical device manufacturers find it a considerable challenge to plan and conduct a cleaning validation. The main challenges are an establishment of the cleanliness limits and an identification of the challenge conditions to be assessed during the process validation. This webinar describes logical and risk-based approaches to overcome these challenges.
$149.00
$249.00
$249.00
Available for Immediate Download

Writing an Effective Human Factors Engineering Procedure

This webinar discusses the need for medical device companies to create a human factors engineering (HFE) procedure that conforms to current HFE standards as well as the standards and expectations of the FDA and other regulators. Learn how an HFE procedure must be closely tied to a company’s risk management process (e.g., ISO 14971) and ways to turn a general procedure into a detailed and properly scaled one to guide a particular product development effort. This webinar serves the remedial benefit of explaining the purpose of the myriad HFE activities comprising a complete procedure. This webinar will enable audience members to immediately prepare appropriate procedures for their own organization.
$135.00
$225.00
$225.00
Available for Immediate Download