
Usability Engineering in Medical Devices
8,200 kr
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 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 new regulations 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.
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 excercises
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 7050 SEK until May 16 and thereafter 8.200 SEK. Documentation and certificate in digital format, lunch and coffee are included in the fee. Printed documentation can be obtained for an extra cost of 500 SEK.
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.
Coming events: Events in English
Date | Date | Event | Days | Location |
30 aug 2022 | aug 30 | 1st Nordic Conference on Computational Chemistry 2022 Gothenburg | 2 | Gothenburg |
29 nov 2022 | nov 29 | Nordic-Baltic HTA Forum – what’s happening nationally, regionally and in EU? Online | 1 | Online |
19 jan 2023 | jan 19 | Analysis of vaccines Online | 1 | Online |
19 jan 2023 | jan 19 | Analysis of vaccines Stockholm | 1 | Stockholm |
Kontakt
i Stockholm AB
Box 1136
111 81 Stockholm
Besöksadress: Wallingatan 26 A
Tel: 08-723 50 00
Fax: 08-20 55 11
E-post: info@lakemedelsakademin.se
Org.nr: 556005-7043

