Usability Engineering in Medical Devices

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.

Feedback on the course and instructor

We ran the course first time spring 2018 and it scored 4,75 of 5 when participants were asked if they would recommend this course to a colleague!

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, MEDQURE, 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 online in our virtual Zoom classroom. The course starts at 08.30  and ends approximately at 16.30 hrs.

Participation fee

Early-bird participation fee is 6.950 SEK until March 13 and thereafter 8.100 SEK. Documentation and certificate in digital format are included in the fee. All prices are excl. 25% VAT.

Other information

For information such as cancellation policy, participant list, GDPR etc – see “Registration Terms” to the right.