- INDUSTRY SECTORS
invenio supports you in all matters relating to the usability of medical devices, also known as usability, as part of your product development or during the life cycle of a medical technology product. When it comes to the usability of medical devices, we focus not only on regulatory requirements but also on all safety relevant and functional issues as well as the worldwide acceptance of the product on the market. The interface between the product and the user is of particular importance. Thanks to our in – house experts from development, regulatory affairs and clinical application for active and non-active medical devices, we are in a position to answer even the most complex questions concerning the usability of medical devices.
In the 'early phase usability' we offer you a much more comprehensive service for usability, especially of very complex active medical devices in development. The focus is primarily on the creation of concepts for the human machine interface of your medical device to be developed. Solutions for the design of the technical side of the interface are developed with special consideration of the clinical area of application and the resulting conditions. Experienced experts from the respective clinical environment are involved in this process.
Produce a complete analysis of the product concept in terms of clinical applicability (Proof of Concept – POC)
Proposals for concrete product design, especially for the design of the human machine interface
Creating a complete concept for the design of a user interface, especially of active medical devices
Developing a product relevant way of dealing with alarm messages, as well as providing an interface and the associated user interface
Implementing interface options such as voice input, gesture control or neural controls
Creation of prepared (functional) prototypes, e.g. for 3D printing or software simulation
Plan and conduct necessary and relevant tests for the usability of medical devices
Comprehensive development of your medical device, thanks to our in house access to all the trades required for this purpose
Developing concepts and planning and conducting usability tests
Ensure compliance with the regulatory requirements of, for example, the EU or the USA (FDA)
Planning final usability tests for worldwide approval with a high probability of a positive test result to avoid high follow up costs
Carry out the tests according to the regulatory requirements
Together we take care of the usability for marketing your product
We create user manuals, analogue and digital support systems, Briefing concepts and other materials.
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