01. Definition usability
The IEC 62366 describes usability as the property of the user-product interface that includes the user’s effectiveness, efficiency, learning facilitation and satisfaction.
02. Advantages of usability workshops
According to the Medical Devices Regulation MDR, a summative evaluation is a regulatory necessity. Formative evaluations by experts during the development process help to detect errors and potentials at an early stage. This saves you time and valuable resources.
03. Your benefits
In addition to the necessary infrastructure, we provide you with the relevant medical personnel for your product in a quick and uncomplicated manner and accompany the execution of the test. You save time, effort and money.
”By working with M3i, we were able to involve a large and diversified number of clinical experts in the product development phase. The findings gained from the end users were a great asset for us.James BergeProduct Manager
- Formative and Summative Evaluation of Usability
- Evaluation of clinical requirements
- Benchmarking against comparable products
- Testing of the product on validated models (from simulator to corpse model) in a realistic environment
- Structured questionnaires and interviews with the test persons
Results for you
- Recommendations for development engineers regarding usability and risk assessment (including feedback loop)
- usability evaluation report (including audio and video data) for the usability file
- Preparation of the optimum test environment (validation planning), creation of a test setup
- Formative and summative usability tests in a realistic clinical environment by clinical experts for structured and realistic user feedback
What clinical resources do you need for your project?
Why you Will Benefit from SimOP
identification and integration
of suitable clinical experts from our network
realistic test environment
for usability testings on validated models
evaluation of usability
by an experienced and independent company
Would you like to know more about SimOP?
Approach, organisation and implementation
Usability workshops with M3i
You are a Human Factors/Usability Testing company?
Check out here how you can benefit from a collaboration: