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 also be able to provide comprehensive documentation to prove that the usability aspects have been applied. 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 who needs knowledge about how the requirements affect your product and product development.
No matter what stage of development you are in, this course will help you plan and include usability in your development process and be compliant with the necessary requirements. During the course day you will get an overview of standard/guidance as well as understanding how to apply them practically.
Recommended prior knowledge: Participants should have a basic knowledge of medical device development and medical device legislation. The course will be held in English unless only swedish speaking participants.
Learning Objectives
After the course you should have gained:
- An overview of current rules for usability for medical devices in EU and US
- Detailed knowledge of the standards IEC/EN 62366-1 and IEC/EN 60601-1-6
- How to apply requirements practically
- 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
Instructor
Micael Johansson, PREVAS, 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 09.15 and ends approximately at 17.00 hrs.
Participation fee
Early-bird participation fee is 8100 SEK until Mar 7 and thereafter 9.800 SEK. Documentation and certificate in digital format, lunch and coffee are included in the fee. All prices are excl. 25% VAT.
Registration and other information
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. For information such as cancellation policy, participant list, GDPR etc – see “Registration Terms” to the right.
Inlägget Usability Engineering in Medical Devices dök först upp på Läkemedelsakademin.