IEC 62366
IEC 62366 Consultancy & Training
The team at Lorit Consultancy has many years of experience in software development in the field of medical technology and is fully conversant in the topic of usability and the standard IEC 62366 application of usability engineering in medical devices.
Whether you need consultancy, support or training – we support your team with our expertise in safe product design.
About IEC 62366
Poor usability in medical devices can lead to hazardous situations and result in harm. The IEC 62366 standard provides a framework for establishing usability processes in the development of a medical device.
Human interaction and the characteristics of the user interface that are intended to facilitate use and thereby establish effectiveness, efficiency and user satisfaction in the intended use environment are important factors that need to be taken into account.
IEC 62366 relation to other standards
Usability and the IEC 62366 standard are primarily strongly linked to the ISO 14971 risk management standard for medical devices.
Another document that is used in a supportive manner and is a pragmatic guide to usability or provides many good practical examples is AAMI HE 75 “Human Factor Engineering – Design of Medical Devices”.
Our services
Consultancy & Support:
- Task & function analyses
- Formative and summative evaluation
- Risk analysis
Training:
We offer (online) training courses that can be customised to meet your requirements in terms of date, format and content.
Learn the basics of IEC 62366 with working examples, team exercises and our industry knowledge and experience. You will get a practical overview of usability processes and get to know the usability scenarios using guidance documents.
