ComplianceOnline

Beyond Usable to Valuable: Usability Testing on Medical Device Labeling

Instructor: Patricia A Patterson
Product ID: 700879

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Apr-2008

Training CD

$500.00
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(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

Usability testing on medical device labeling can help avoid these consequences and improve your return on the investment (ROI).

Description

Usability testing is a ’Best Practice’ method for assessing the efficacy of your labeling and enhancing its value to your users.

Imagine being able to anticipate how the FDA and users might react to your medical device labeling before launch. Usability testing helps you do this by providing an objective assessment of its effectiveness and usability. Based on recent reviews of device submissions, the FDA has expressed concern that most labeling is ineffective and unusable by the intended user; professional or lay, and may be a source of use errors leading to adverse events. As the same time, we know that most users don’t read the manual. Usability testing is a ’Best Practice’ method for assessing the efficacy of your labeling and enhancing its value to your users.

Medical device labeling includes paper-based user manuals and quick start guides or electronically delivered videos, DVDs or web-based tutorials and can consume 20% or more of the cost of a new product. Regardless of cost, ineffective labeling produces economic consequences that can: negatively impact clinical studies, hinder FDA approval, delay launch dates, spike costly Customer Support calls, and in worse cases, provoke liability claims. Usability testing on medical device labeling can help avoid these consequences and improve your return on the investment (ROI).

Areas Covered in the seminar:

  • What are the key FDA standards and guidelines regarding medical device labeling.
  • Recognize how labeling fits into your overall risk management plan.
  • Explain use error risk and labeling as a mitigation strategy.
  • What are the types of usability testing and when to use them.
  • What are critical tasks in conducting a usability test on medical device labeling?
  • What are the ’real’ costs of labeling.

Who will benefit:

This session will benefit those who develop, manage, or audit user labeling for medical devices. Depending on your organization, this could include professionals in:

  • Engineering
  • Regulatory
  • Quality Control
  • Quality Assurance
  • Packaging and Clinical Affairs

Instructor Profile:
Patricia A. Patterson, CPT is a Certified Performance Technologist and President of Agilis Consulting Group, LLC. For more than 25 years Pat has applied the systematic, research-based methodologies of Human Performance Technology (HPT) to improve how people learn to use information and technology to produce measurably superior results. Pat is an industry member of the FDA’s Home Healthcare Committee focused on reducing the number of adverse events in this growing segment of the medical device industry. She is also a contributing author to the user documentation/training change in HE 75: Human Factors Design for Medical Devices, currently being developed by the Association for the Advancement of Medical Instrumentation (AAMI) for eventual adoption by the FDA, expected later this year. Pat is also a frequent speaker and author on the subject of labeling and training has published several articles in Medical Device & Diagnostic Industry and the Regulatory Affairs Professional Society (RAPS) Focus magazinene.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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