We support your teams throughout the fitness-for-use process, from preliminary analysis to the creation of documentation that complies with regulatory requirements. Our approach integrates user experience design and a dual formative and summative evaluation, to ensure that medical devices are safe, intuitive and adapted to users' real needs.
Thanks to our complete mastery of the key stages - risk and usage analysis, UX/UI and product design, user evaluations and compliance with the IEC 62366-1 standard - we secure the development of your interfaces and boost the performance of your product from the very first phases of the project.
From preliminary analysis to documentation of the fitness-for-use process,
we offer end-to-end support, including user experience design
and its dual formative and summative assessment.
Studying usage contexts to fully understand user needs and anticipate potential user errors. We draw up the expected functionalities and verifiable specifications to ensure the reliability of the design of the future user interface.
Design user interfaces (digital or tangible) that are simple, secure and effective, in line with the specifications defined upstream. We can also work on integrating an aesthetic in line with the brand identity you wish to convey.
Identify the strengths and weaknesses of one or more concepts to enhance understanding of usage. Then demonstrate the safe use of your DM through a protocolised test on a panel of representative users.
Train your teams and provide model documents for drawing up a fitness-for-use engineering file in compliance with IEC 62366-1: 2015. We can also draw up these documents for you.
We provide you with modular, tailor-made solutions
depending on your needs and the stage of your project.
Document all user interface design activities in a usability engineering file:
We can help you integrate the IEC 62666-1:2015 process into your company:
Obtain user feedback at various stages of the design process to improve or validate a design:
Anticipate human factor risks with regard to the characteristics of the users, the solution to be designed and the tasks to be carried out:
Capture and analyse user insights to enrich the design and validate the final design:
Design reliable, simple and visually appealing user interfaces:
A team with expertise in interface design and validation for the medical sector.
One entry
in your processes
Our expertise is deployed within a framework that complies with the requirements of IEC 62366-1. What's more, our dedicated team knows and understands all the issues involved in the design and validation of a medical device, so we can integrate efficiently into your other processes (ISO 13485, ISO 14971, IEC 62304).
A global view
view of design
Beyond regulatory compliance, we guarantee you the support of the leader in human-centred design, to find design solutions (product & software) adapted to the needs of users and the identity of your company. We help you stand out from the crowd through the performance and aesthetics of your products.
Expertise
on digital integration
We were born 40 years ago out of the digital transformation of a complex, high-risk process: our genetic make-up gives us all the keys we need to support the digital revolution in HealthTech. Whether your product is natively digital or incorporates a connected dimension for the first time, we know how to make the most of digital.
Our experience in a wide range of medical specialities covers both complex equipment for healthcare professionals and products for patients. This experience and our network enable us to quickly understand the specific uses of your products.
We are working with a number of surgical robotics and navigated surgery start-ups. From risk analysis to formative and summative assessments, via the design of software interfaces, we are at the heart of the design and validation of these innovative technologies.
We design innovative drug delivery systems, which are increasingly connected. Through a synergy between ergonomics, UX/UI design and industrial design, we help to create a positive and engaging patient experience that promotes therapeutic compliance.
Products that appear simple and well-known (catheters, surgical kits, implant ancillaries, etc.) sometimes raise problems of fitness for use. We work on both the ergonomics and the validation of these products (design and formative/summative evaluation) to make them simple and safe to use in the day-to-day work of carers.
Contact us to discuss the best strategy for your project!
