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Usability Engineering & certification

IEC 62366-1

Support throughout
the fitness-for-use process

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.

Interventions

Design of medical devices
and IEC 62366-1 compliance

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.

Risk analysis
& uses

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.

UX/UI design
& Product

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.

Formative assessments
and summative

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.

lIEC 62366-1 compliance

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.

Health offer

A whole range of solutions

We provide you with modular, tailor-made solutions
depending on your needs and the stage of your project.

Compliance
IEC 62366-1

Document all user interface design activities in a usability engineering file:

  • Dangerous phenomena and situations,
  • Characteristics of the safety interface
  • Validation plan
  • Formative / summative test reports
  • Conclusion on risk management

Training / Template
IEC 62366-1

We can help you integrate the IEC 62666-1:2015 process into your company:

  • Training on the approach
  • Workshop / Action plan
  • Transferring document templates
  • Proofreading your files

User tests
(formative / summative assessment)

Obtain user feedback at various stages of the design process to improve or validate a design:

  • Drafting the test protocol
  • Recruitment of testers (healthcare professionals and patients)
  • Preparing the test environment
  • Moderation of test sessions
  • Analysis of results and evaluation report

Analysis and control
risks

Anticipate human factor risks with regard to the characteristics of the users, the solution to be designed and the tasks to be carried out:

  • Specifications for use
  • Risky use scenario
  • Use-FMEA / Fault tree
  • Risk mitigation measures
  • User interface specifications

Understanding
uses

Capture and analyse user insights to enrich the design and validate the final design:

  • Business analysis, REX study
  • Ethnographic study (field observation, individual interviews, focus groups)
  • Quantitative study (questionnaire)

UX / UI design

Design reliable, simple and visually appealing user interfaces:

  • Defining user paths
  • Low-res mock-up (Zoning / Wireframe)
  • Graphic design / visual identity
  • High-fidelity model (static / dynamic)
Medical devices

Our strengths

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.

A wide range of medical applications

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.

Surgical robotics

Designing the surgery of the future

We are working with a number of surgical robotics and navigated surgery start-ups.

Securing surgical innovation

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.

UX/UI Design and connected health

Improving the patient experience

We design innovative drug delivery systems, which are increasingly connected.

A holistic approach

Through a synergy between ergonomics, UX/UI design and industrial design, we help to create a positive and engaging patient experience that encourages compliance with treatment.

Ergonomics and Usability

Making everyday life easier for carers

Simple, well-known products (catheters, surgical kits, implant ancillaries, etc.) sometimes raise issues of fitness for use.

From design to summative validation

We are involved in both the ergonomics and the validation of these products (design and formative/summative evaluation) to ensure that they are simple and safe to use in the day-to-day work of carers.

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    Over 40 years' experience

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