Medical Device Usability
The participants will achieve an understanding of how to document the usability of medical devices in order to achieve compliance through an introduction to the usability engineering process, a thorough walk-through of the requirements in IEC 62366-1 and -2 and the FDA Human Factor Engineering guide, and practical application of usability techniques during design and post marketing.
Outcome
The participants will achieve an understanding of how to document the usability of medical devices in order to achieve compliance through an introduction to the usability engineering process, a thorough walk-through of the requirements in IEC 62366-1 and -2 and the FDA Human Factor Engineering guide, and practical application of usability techniques during design and post marketing.
Content
Usability of medical devices and the documentation of the usability engineering process have become increasingly important for the medical device industry. During the course, the participants will learn about the usability engineering process including specification of a medical device application with focus on user interface, identification of hazardous situations related to usability, handling of risk related to the user interface and the summative evaluation of the user interface design. Preparation of the usability engineering file will be described and different methods for integrating the file in development documentation will be suggested.
Who should attend
This course is targeted at (but not limited to):
- Usability Engineers
- Product design engineers
- Risk managers
- Regulatory managers
- Project managers
- Quality managers
Trainers
Peter Bøge
Design Control Specialist, Novo Nordisk A/S
Peter Bøge has extensive experience in design control, risk management and usability engineering for medical devices. On this course, he guides participants through the regulatory framework for usability, including IEC 62366-1 and AAMI HE75 and their connection to risk management, design development and the usability engineering file. His long-standing involvement in international human factors standardisation provides valuable insight into both the intent and practical application of the requirements.
Marianne Witt
Senior Human Factors Specialist, Zealand Pharma
What previous participants said
Contact
Select date
23-24. november 202620-21. maj 2027
22-23. november 2027
23-24 November 2026 - at 09:00 - 16:00
Price ex. VATLatest Registration
16.11.2026
Latest Cancellation
02.11.2026
Bøge Allé 5, 2. th
2970 Hørsholm
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Terms
In-house Courses
MedTech Academy offers in-house training courses tailored to your specific needs. Courses can be based on our open programme or developed specifically for your organisation. You choose the focus, format and timing – and work with your own cases in a confidential setting. Contact us to discuss the possibilities.
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We continuously develop and update MedTech Academy’s course portfolio to match the current needs of medical device companies. If you are looking for a specific course, or if you are unsure which course is the right fit for you and your organisation, you are always welcome to contact us.
Berit Munkebo
Head of Development
bm@medicoindustrien.dk
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Academy News is Medicoindustrien’s weekly newsletter with a complete overview of upcoming and newly developed courses from MedTech Academy. The newsletter provides a quick overview of new dates, upcoming sessions and current course topics for professionals working with medical devices.