Usability of Medical Devices in Practice workshop 13.11.2024
- Date:
- 13.11.2024 - 13.11.2024
- Credits:
- 0
- Location:
- Kuopio
- Continuous learning category:
- Social welfare and health care, Technology and digitalization
- Teaching format:
- Contact teaching
- Price:
- 0 € (VAT 0%)
During the workshop we go through basics of usability through the regulatory requirements, standards and practical applications.
The aim of the training is to gain insights into usability, it’s pitfalls and best practices on how to have target audience in mind when developing medical device for intended users.
After the workshop, the participant will be able to
- describe the significance of regulation in terms of usability and the practical challenges in placing medical devices on the market
- identify the relevant standards and their relation to quality management and risk management systems
- give practical examples on how to implement the usability into practice
Sign up for the training and return your pre-assignment (is a part of registration form) by Monday, 4 November 2024.
Please, note that the training capacity is limited to 30 first registered.
Personnel working on medical device design and development, medical device software engineers and management. Especially well suitable for Usability/UX-, Quality- and Regulatory personnel of health technology start-ups.
Wednesday, 13 November 2024 at 10.00 – 15:45.
University of Eastern Finland, Tietoteknia building, seminar class 1035 (Savilahdentie 6, 70210 Kuopio).
This training is free of charge.
Usability of Medical Devices in Practice workshop is part of the free training offered by the ReguVa-project (Boosting Regulation and Sustainability Competence for Health and Wellness Sector). The project is co-funded by the EU.
The training session and materials are in English (except Ilpo Pöyhönen`s presentation will be given in Finnish). You can join the discussion in English or in Finnish.
Once you have registered to the course, you will receive a pre-assignment. Please return it by Wednesday, 4 November.
By filling out the pre-assignment
- You add value to your training day and tune yourself into the theme of the day.
- The collected information will be used to tailor the training day to the needs of the participants.
- You will know basics of the usability and how to take it into account in designing and developing of a medical device.
- You will have an insight of relevant standards and their relation to quality management and risk management systems.
- You will receive practical tips for your work and feedback on your medical device usability.
- You will network and exchange ideas with colleagues.
Usability of Medical Devices in Practice workshop 13.11.2024
Program
10:00-10:15 Registration
10:15-10:30 Introduction to training day – Medical device regulations and usability
- Importance of Usability testing and the implementation of requirements into practice
Hekko Pulkkinen, Project Planner, University of Eastern Finland, Department of Technical Physics
Design for medical products
10:30-11:15 Regulative aspects
- MDR and IDVR
- Usability related standards
- Documentation
- Typical flaws
llpo Pöyhönen, Senior Specialist, SGS Fimko Oy
11:15-12:00 How to translate requirements into practice
- Planning usability activities
- Use error identification
- Usability testing and confirming safe use
Virpi Lahdenmäki, Principal engineer, visualization and usability, GE Healthcare
12:00-12:45 Lunch break (self-paid)
Workshop
12:45-13:00 Group work instructions, Ilpo Pöyhönen and Virpi Lahdenmäki
13:00-14:00 Workshop, part I
14:00-14:30 Coffee break
14:30-15:15 Workshop, part II
15:15-15:30 Workshop – discussions and conclusions
15:30-15:45 Summary and conclusion of the day, Hekko Pulkkinen, Project Planner, University of Eastern Finland, Department of Technical Physics
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