Objectives of the Presentation
Why Should you Attend
- The regulatory status of the new standard
- The many revised definitions
- The new concepts of formative and summative evaluation
- The inputs to the User Interface Specification
- The elements of the User Interface Evaluation Plan
- The application of the evaluation plan to the design, demonstrating safety
Medical device manufacturers need to stay current with the changing standards. This is particularly important for products with the CE Mark; the technical file or design dossier should include information on the application of harmonized standards when they change. The changes in this standard are significant, and companies need to develop a strategy for the change.
In February 2015, the usability engineering standard, which had been in place for about eight years, became obsolete. The new version, IEC 62366-1:2015, has a very different structure. Medical device manufacturers will need to implement this approach as part of the risk management system. For example, usability engineering applies to information for safety, as a risk control measure, to ensure users understand it.
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.
Who will Benefit
- 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
Participants will receive bonus material to help them implement the new version of the standard: The Usability Engineering File has prescribed contents. A checklist will help ensure the file structure is correct and includes the required documents and records.