Suitability for use of medical devices

Ensure the Usability of Your Medical Devices with Comprehensive Usability Tests

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.

That's why Early Phase Usability makes us unique!

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. 

Our early stage usability services:
  • 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

  • Designing enclosure concepts under ergonomic criteria with specialised designers
  • 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

Further services for the fitness for use of medical devices

Formative Usability

  • Developing concepts and planning and conducting usability tests

  • Ensure compliance with the regulatory requirements of, for example, the EU or the USA (FDA)

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  • In the first place of the formative usability tests is the concept creation under consideration of the 'Intended Use' as well as the complex analysis of the field of application. The tests, which are still carried out at various stages of development, are conducted in the usability laboratory with users from the field who can assess the functionality of the user interface. All usability tests of the medical device are carried out according to European and US requirements and documented in a regulatory compliant manner.

Summative Usability 

  • 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   

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  • Summative usability tests are used for the final evaluation of the usability of medical devices for worldwide approval. They are usually carried out with the fully developed product. Such summative tests are handled by invenio when we can assume with a high degree of probability that the test results will be successful for approval. It is highly cost and time intensive if the test results are negative. Consequently, technical adjustments must then be made. The aim of invenio is to avoid exactly this.


  • 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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  • Under our strict consideration of the usability criteria of medical devices, we are able to offer you the creation of user manuals, Instruction for User (IFU) and help systems in both analogue and digital form. Special attention is paid to the comprehensibility by the users as well as the interactive provision of required information.
  • In addition, we can also provide you with the required instruction concepts and materials from a strict clinical perspective.

Would You like to contact us?

Gladly we are at your disposal for any questions! 

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