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.
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.
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
Course Provider
Daniel O Leary,
