ComplianceOnline

Implementing the New Usability Engineering Standard

Instructor: Daniel O Leary
Product ID: 704894
  • Duration: 90 Min

recorded version

$279.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$379.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

Usability Engineering has become a major topic. The current standard tightens the linkage to risk management. In addition, there are changes in the US and EU approach, all of which find a basis in this standard. Attending this presentation provides the information you need to prepare for these major changes.

Bonus Download:

The Usability Engineering File has prescribed contents. A checklist will help ensure a correct file structure that includes the required documents and records.

Why Should You Attend:

IEC 62366-1:2015 is the current standard for usability engineering. Medical device manufacturers should implement this approach as part of the risk management system. For example, usability engineering applies to information for safety as a risk control measure.

Device manufacturers will transition to the new standard, meaning new procedures, additional training, and a new structure for the Usability Engineering File. Part of this transition includes using new concepts introduced in the standard. For example, the standard requires formative evaluation and summative evaluation, which are not common concepts in medical device design and production.

This presentation provides information you need to help implement the new standard. It offers details on the new concepts, highlights the many revised definitions, and provides a conceptual model to help you understand the approach. For example, the presentation uses examples that illustrate use error and show the relationship to risk management terms such as hazards and harms.

Areas Covered in the Webinar:

  • Learn the regulatory status of the standard in the US, EU, and Canada
  • Review the updated definitions so critical to effective implementation
  • Understand the concepts of formative and summative evaluation
  • Learn the inputs to the User Interface Specification
  • Know the elements of the User Interface Evaluation Plan

Who Will Benefit:

This presentation supports all medical device companies engaged in design and risk management. The implementation requires coordination across many areas including:

  • Design Engineering Managers
  • Interface designers, including software engineers
  • Technical writers providing instructions for users
  • Usability engineers
  • Risk managers
  • Professionals involved in complaint management and MDR reporting

Instructor Profile:

Dan O'Learyis President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and certified by APICS in Resource Management.

Follow us :
ComplianceOnline Banking Summit 2016 | Risk Management and Data Security - 80390SEM
ComplianceOnline Medical Device Summit 2017

Product Reviews

This product hasn't received any reviews yet. Be the first to review this product! Write review

Best Sellers
You Recently Viewed
    Loading