All About UOUP (Usability of Unknown Provenance) A Guide to Creating a Usability Engineering File Retrospectively

Why Should You Attend:

Internal and external auditors are looking more closely at medical device companies’ ability to ensure that products commercialized prior to IEC62366-1 Application of usability engineering to medical devices (2_2015) has been considered. Your company may have excellent standard operating procedures that consider Human Factors Engineering for new medical devices in place, but what about the older commercialized products? Annex C of IEC62366-1 asks that question and provides guidance on how to efficiently provide evidence that usability was considered for older products ensuring their safe, effective, and efficient design. Do you understand UOUP? Can you retrospectively create a Usability Engineering File? This webinar will ensure you can.

As per Annex C (Evaluation of a USER INTERFACE OF UNKNOWN PROVENANCE (UOUP) of IEC62366-1 Application of usability engineering to medical devices, companies who are manufacturing medical devices prior to the creation of the standard may be interested in applying the tools defined in the standard to user interfaces or parts of the user interfaces that have been commercialized prior to the standard itself. This process relies on using existing product documentation created during the development of the legacy user interface using organizational resources in an efficient manner.

This webinar provides individuals with an opportunity to understand what UOUP is and how to provide what Annex C of IEC62366-1 requires for products commercialized prior to its creation. Unlike a new product’s Human Factors deliverables, a product commercialized prior to the standard may use other sources of evidence that illustrate it has been designed to be safe, effective, efficient, and free from use errors. This webinar will demystify the deliverables of Annex C of IEC62366-1, help you understand the deliverables required and provide the ability to move forward confidently when assessing additional products commercialized prior to the standard.

Areas Covered in the Webinar:

• What is Usability of Unknown Provenance (UOUP)
• Why is it important
• What does Annex C of IEC62366-1 require
• What resources and documents can be used to retrospectively create a Usability Engineering (UE) File
• Who creates the Usability Engineering File
• How to retrospectively create a Usability Engineering File
• UE File template
• What to do if some of the UE File deliverables are missing
• How to move forward when you have many products commercialized prior to the standard

Who Will Benefit:

• Human Factors Engineer
• Usability Engineer
• Project Manager
• Systems Engineer
• Quality Engineer
• Risk Management
• R&D Leadership
• Customer Service
• Field Service
• Training

Elizabeth Bononno
Owner and Founder, EB-UX Consulting, LLC

Elizabeth Bononno is an accomplished business owner, AAMI Human Factors Board Member and Certified Usability Analyst who brings a diverse skill set to strengthen and improve the client and user's experience. Her experience spans over 25 years of practical Marketing, Product Management, User Experience and Design Validation knowledge with medical devices and business to consumer website content research, development and analysis. Her mission is to ensure the customer and device interface quality come first through the education of teams, effective interpretation of industry standards and creation of functional practices that establish a customer focused culture and a trusted, empowered organization.

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