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