IEC 62366-1 - Usability Engineering of Medical Devices Training Course
- You will learn how to systematically develop medical devices that are fit for use and safe to use.
- You will know how to avoid user errors through clever design of medical devices.
- You will receive concrete information on the efficient implementation of the normative requirements for the usability of medical devices.
Usability Engineers, User Experience Designers, Quality Assurance, Research and Development, Product Management, Risk Analysis, Employee Regulatory Affairs
- Legal basis, in particular MDR and IVDR
- Structure and requirements of IEC 62366-1:2015
- Terms and basic principles
- Usability Engineering Process
- Linking usability engineering with risk management according to ISO 14971
- Methods for analyzing the context of use (user and usage environment)
- Embedding usability engineering in innovation projects and product development:
- Use Specification
- Analyze use errors with hazard-related use scenarios
- Relationship between use errors and risk analysis
- Integration of use scenarios in system and software requirements documents
- Setting Up User Interface Requirements for the User Interface Specification
- Planning, implementation, evaluation of usability tests
- As formative user interface evaluations
- As a summative user interface evaluation and part of the validation
- Other sources – ISO 9241 series of standards, AAMI HE 75
- Additional requirements of the FDA regarding usability engineering/human factors engineering
- The IEC 62366 standard aims to reduce errors caused by inadequate medical device usability. Such errors have become an increasing cause for concern. IEC 62366 is a process-based standard that aims to help manufacturers of medical devices to design for high usability.
- The contents of the seminar correspond to the current state of revision/harmonisation.
- The seminar deals with internationally valid standards and is also suitable for implementation abroad.
Upon Completion you will receive your globally recognised TÜV SÜD certificate on IEC 62366-1- Usability Engineering of Medical Devices
TÜV SÜD tests and certifies through its Notified Bodies medical devices and their manufacturers. TÜV SÜD Academy UK offers trainings in the field of medical devices.
The neutrality and independence of the conformity assessment procedures carried out by TÜV SÜD must be maintained. In the interest of our customers, hence the seminars of TÜV SÜD Academy do not contain any product-specific, process-related or company-specific content or solutions that could fulfill the function of individual consulting.
In case of any questions or uncertainties, please do not hesitate to contact us.