Ergonomics for medical devices specialist

(IEC 62366 - MDR 2017/745)

Leader in Usability Engineering for medical devices since 2015, UseConcept takes care of your products ergonomics and helps bringing your medical devices to market by answering regulatory requirements both for CE and FDA marking.

Our services
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Plaquette de UseConcept - Ergonomie pour l'innovation et les nouvelles technologiesL'image représente un ergonome dans une salle de régie en train d'observer un test utilisateur grâce à la vitre sans tainJulien Aldegheri et Nicolas Leroy en train d'évaluer un dispositif médical
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The EN 62366 standard no longer holds any
secret for UseConcept!

MDR 745FDA GuidanceUsabilityEN 62366-1:2015 /A1 IEC 62366-2:2016
Thanks to our triple expertise in regulatory standards, ergonomics and health, our experts team helps you from the beginning to the end of your device's conception process.

UseConcept is specialized in the application of  Usability EN62366-1:2015 standards.Our Human Factor and Ergonomics experts support you throughout your device's conception process as well as in all the different steps towards your product's certification.
L'image représente la méthode du test utilisateur, illustré par un ergonome de UseConcept dans une salle d'observation
Assessment

User testing

Applied in the Medical Devices Formative Evaluation or Summative Evaluation phases

L'image représente un atelier de créativité
Conception

Creativity workshops

Allows users' involvement during the product or service's conception phases.

L'image représente une analyse de l'activité avec un ergonome et un utilisateur.
Analysis

Activity analysis

Allow to identify the risks of error and to optimize the design.

More of our methods

UseConcept in Figures equals...

420

Projects

280

Suitability for use: CE marking

17

Usability for
FDA Approval

28

Readability tests for AMM

11

SSCP Assessments

5 425

User tests

42

User interface designs

45

Post Productions

140

formations

87

Creativity workshops and focus groups

L'image représente l'une des salles des locaux de Useconcept

Our User Experience-dedicated facilities

More than 2000m2 dedicated to health studies

Discover our infrastructures

They trust us

Logo LNELogo StiplasticsLogo VoluntisLogo DiagastLogo UrgoLogo CardiologsLogo Electro ducerLogo Sotway MedicalLogo Laboratoire de la merLogo E deviceLogo CetimLogo Lyra
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Our references
Logo Diagast

"From the definition of the needs to the PIAU final report delivery, every step was perfectly managed by the UseConcept team."

Marketing Manager, Diagast
Logo Septodont

"A good mastery of the topics. The team is available and quickly understands your needs."

Septodont
Logo Getinge

"Good understanding of the projects and products. Good investment of the UseConcept's team and real reactivity in case of need."

Getinge
Logo MyBrainTech

"Competent, reactive, attentive, respectful of the deadlines. They adapt to the client's needs and are very welcoming !"

My Brain
Logo Robocath

"Quality discussions, availability of the team, very complete deliverables even when they never saw the device (HMI expert review). Their comments are always very relevant and useful regarding the progress of our CE marking file."

Robocath
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Discover our latest news

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2 min

There is still movement at UseConcept. Welcome Antoine!

After the arrival of Tamara, it is Antoine's turn to join the UseConcept team!
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2 min

A wind from the South is blowing on UseConcept!

We all welcome Tamara. And who says arrival says presentation:
Read the article
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2 min

First edition of the Usability Days

This year marks an important milestone for UseConcept: we are celebrating 10 years of existence!
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Let's talk about a project

Contact us!
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Event day!

To celebrate our 10th anniversary, we are organizing the Usability Day, a day dedicated to human factors in the development of medical devices organized by UseConcept.

Attending in personAttending remotely