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Webinar Recording: Maximizing the Value of ACI Certification and Understanding Recertification Requirements

Earning ACI's certifications can give professionals the career advancement they're looking for by validating their knowledge base, demonstrating their commitment to the field, and showcasing their devotion to continued education. Join this webinar, given by AAMI's Certification Manager, Martin McLaughlin, to learn how to maximize the benefits of certification within your organization and to better understand the process of maintaining your designation once it's earned.
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Writing a Human Factors Engineering (HFE) Report

In 2011, the U.S. Food and Drug Administration (FDA) released a draft guidance document, Applying Human Factors and Usability Engineering to Optimize Medical Device Design, and this guidance calls for medical device manufacturers to include an HFE report when they apply for a 510(k) or PMA. The FDA goes so far as to provide a relatively detailed outline for the HFE report. However, many manufacturers are likely to have persisting questions about how to write an effective report.
$135.00
$225.00
$225.00
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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
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Writing Human Factors Plans and Reports Webinar

This webinar will fill a perceived gap in the guidance available to medical technology developers with sample work products and supplemental job aids that offer document preparation advice and have been peer-reviewed by a panel of HFE experts.
$149.00
$249.00
$249.00
Available for Immediate Download