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.
Learning Objectives
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
Course Outline
- 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
Speaker
Micael Johansson, NIMIO AB, Stockholm The course is developed in collaboration with the scientific section for Medical Devices at Swedish Pharmaceutical Society.
Time and Venue
The course is held at Apotekarsocieteten, Wallingatan 26A in Stockholm. The course starts at 09.00 and ends approximately at 16.30 hrs.
Participation fee
The participation fee is 6.900 SEK until February 12 2019 and 8.000 SEK from February 13. Documentation in digital format, certificate in digital format, lunch and coffee are included in the fee. All prices are excl. 25% VAT.
Registration
In order for us to offer all our participants the best possible quality, please register your application no later than 72 hours before the start of the activity. At short notice, please contact the project administrator for the activity via email.
Participant list
Participant list We usually share a list of participants during the first course day. Many participants request these lists when taking our courses and we see networking as an important part of the professional development. With reference to this, we assume that our participants have an interest in us sharing the list and the lawfulness of processing the personal data is therefore the legitimate interest. The lists contain first and last name and organization. If you do not want your name and organization to be included in the participant list, please notify the project administrator at the time of registration or else as soon as possible. If you have questions regarding the participant list, you are welcome to contact the responsible project administrator.
Inlägget Usability Engineering in Medical Devices dök först upp på Läkemedelsakademin.