IEC 62366-1 - Usability Engineering of Medical Devices Training Course

Usability Engineers, User Experience Designers, Quality Assurance, Research and Development, Product Management, Risk Analysis, Employee Regulatory Affairs

Usability is an important safety and performance feature ofmedical devices. The Medical Device Regulation (MDR, 2017/745) and the In VitroDiagnostics Regulation (IVDR, 2017/746) place significantly higher requirementson usability, which are not fully covered by EN 62366-1:2015 + AMD1:2020.However, EN 62366-1 + AMD1 represents the state of the art for manyrequirements.

All of these regulatory requirements require usabilityengineering in the development process of medical devices. In this trainingcourse, you will learn to understand and implement the requirements of thestandard. Good usability offers the opportunity to stand out from thecompetition and create enormous added value with the right methods.

This training course shows how the regulatory requirementscan be implemented and at the same time how the greatest possible added valuecan be created through good usability.

• 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.