Medical devices must meet certain requirements to be marketed in Europe and the United States. In the United States (through the FDA) it has been important for many years to apply the usability aspects during the product development; you should be able to provide documentation to prove that the usability aspects have been applied. In many cases, manufacturers have been obligated to make major changes in the design in order to show that the product meets the requirements. In Europe, this will also come more into focus with the new regulations for medical devices (MDR / IVDR).
Who should attend?
This one-day course is aimed at those in the field of medical devices and who needs knowledge about how the requirements affect your product and product development. During the course day you will get an overview of new regulations as well as understanding how to apply them practically.
After the course you should have gained:
• An overview of current rules for usability for medical devices in the EU and the US
• Detailed knowledge of the standards IEC / EN 62366-1 and IEC / EN 60601-1-6
• Practical exercises in usability for medical devices
- Background to the area of usability
- Standard EN 62366-1 in detail and the connection to the regulations and background of EN 62366 and EN 60601-1-6.
- Overview of FDA’s “Applying Human Factors and Usability Engineering to Medical Devices”
- Overview of the close link to risk management
- “FDA’s Applying Human Factors and Usability Engineering to Medical Devices” and 62366-1, what is the difference?
- Practical examples and exercises
Micael Johansson, NIMIO AB, Stockholm
Time and venue
The course is held at Apotekarsocieteten in Stockholm, and live streamed to Oslo Cancer Cluster Incubator to a smaller/medium sized audience where there will be possibilities to ask questions to the lecturers in real-time, as well as having discussions within the local group. The course starts at 09.00 and ends approximately at 16.30 hrs.
The participation fee is 6.700 SEK until April 15th, and 7.800 SEK from April 16.th. Documentation, certificate in digital format, lunch and refreshments are included in the fee. All prices are excl. 25% VAT.
Registration: Please contact Project Administrator, Jenny Hagberg at: firstname.lastname@example.org
Questions: Please contact Ania Johansen at: email@example.com
Oslo Cancer Cluster will be collaborating with the Swedish Academy of Pharmaceutical Sciences (SAPS) and Innovation Norway, to offer you educational courses of high quality in different fields related to drug development. The courses will be held in Stockholm, but will be live streamed to OCC Incubator with a moderator and with interactive functions to participate in the course. Refreshments and lunch is also included.
The aim for the live streaming is to create an attractive, cost- and time effective alternative based upon these educational courses. The audience will be a smaller/medium sized group, which will have the possibility to discuss and share between them, as well as asking questions to the lecturers in real time. The entire course will also be available to all participants for 30 days, through a video of the stream and the slides used.