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Human Factors: Navigating the Regulatory Trenches, New Guidance and Usability Requirements


Earlier this year, FDA released the "Applying Human Factors and Usability Engineering to Optimize Medical Device Design" Draft guidance.

With increasing emphasis, regulated agencies, including the FDA, are requiring medical device manufacturers to be more diligent in making sure they meet the expectations of usability of devices to reduce use error, injuries and product recalls. Human factors activities are required to accomplish this, such as identification of use related hazards, designing out hazards, usability evaluations and validation testing.

During this 90 minute webinar, Jason Fouts, Stephanie Seraphina and Kari Rice, a team of experienced human factors engineer consultants from the Mobia Group, will present information and methods to help you understand what is expected and how to address regulatory expectations related to human factors and usability. Special emphasis will be placed on the new human factors guidance document recently published by the FDA; 60601-1 3rd Edition and IEC62366 will also be discussed.

Attendees will hear what is expected for human factors activities and deliverables throughout the product development process. Real world examples will be provided. The main focus of this webinar will provide you with the information and tools you need to learn how these items can be accomplished during product development.

Key topics include:

  • Intended device users, uses, use environments, and training
  • Device user interface and summary of known use problems
  • User task selection, characterization and prioritization
  • Summary of formative evaluations and Validation testing
  • FDA expectations, 60601-1 3rd Edition
  • IEC62366 (Medical devices – application of usability engineering to medical devices)

For one low price, you and your entire team can take part in this fast-paced, insightful webinar. Best of all, you’ll be able to connect personally with our speakers when we open up the phone lines for live Q&A.


 

FEATURED SPEAKERS

Stephanie Seraphina

Stephanie Seraphina

Human Factors Engineer

Mobia Group

Stephanie Seraphina has fifteen years of experience as a Human Factors Engineer with substantial medical product development experience. Her expertise includes all phases of product development process and experience with shipping over 30 products. She has a proven ability to plan, design and develop products that meet or exceed customers’ expectations. Broad experiences (management and direct contributor) with the various functions that contribute to the end customer experience: research, product management, product design, systems engineering, design verification and validation, and product documentation/labeling.


Kari Rice

Kari Rice

Human Factors Engineer

Mobia Group

Kari has ten years of experience as a Human Factors Engineer working in diverse medical device teams with competing demands. She has a proven record of taking product from conception to release while following a user-centered design process. She is able to help product development teams meet user needs while considering business objectives and communicating effectively with customers and team members. Kari is adept at applying human factors methods to all components of medical device development (e.g., hardware, software, instructions for use, packaging, etc.)


Jason Fouts

Jason Fouts

Human Factors Engineer

Mobia Group

Jason has thirteen years of experience as a Human Factors Engineer working to provide product design stakeholders with user insights and analysis to build more intuitive and innovative products. He has been primarily responsible for defining user requirements, workflow analysis, interaction design, satisfaction of FDA human factors requirements and validation testing. He has a proven ability to work with cross-functional teams to ensure that products are safe, effective and easy to use.


Stephanie, Kari and Jason (along with Brian Epps) work together at Mobia Group, which is a team of experienced human factors engineers helping medical device manufacturers create safe, effective and usable solutions. Mobia's consultants have experience working in a variety of clinical domains and have joined together to leverage each individual’s unique experiences and strengths to better serve medical device manufacturers. Mobia Group specializes in the healthcare industry and has knowledge of all the major regulations related to human factors and usability.

REGISTRATION

Audio CD & Transcript

Audio CD & Transcript

$349

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24/7 ENCORE Audio Presentation

24/7 ENCORE Audio Presentation

$349

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Cancellations: Webinar registrations may not be cancelled. Registrants may substitute the 24/7 ENCORE Audio Presentation for the Live Webinar at any time. Please contact Customer Care to make substitutions.