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Usarea references

They trust Usarea

I support medical device manufacturers and healthcare organisations on usability, CE marking, FDA Human Factors and IEC 62366-1 training projects.

Medical software, mobile apps, imaging, implantable devices: every engagement is built on the same requirement for clarity, rigour and adaptation to the manufacturer's context.

Let's discuss your project

PROJECTS

Projects across a range of devices and markets

The references presented below correspond exclusively to engagements carried out by Usarea.

Logo APELEM
Medical imagingCE marking
Logo Fondation Médecins Sans Frontières
Medical mobile applicationCE marking
Logo Myopowers
ImplantableCE marking
Logo MSInsight
Medical softwareIEC 62366-1 training
Logo Kephalios
ImplantableCardiology

TESTIMONIALS

What clients remember about working with Usarea

I highly recommend Amandine for her support on usability processes. Her responsiveness, quick grasp of our products and their challenges, and her ability to adapt to our existing manufacturer documentation are real strengths. She knows how to fit effectively into an already structured environment while bringing real added value to the process. The quality of the documentation produced also deserves mention: the deliverables are clear, well-structured and of high quality. Amandine is a reliable, professional and efficient provider, whom I recommend without hesitation.

Logo APELEM

Alex B. - APELEM

Over 10 years of experience across a wide range of medical devices

Beyond the references carried out under the Usarea name, my career has allowed me to support more than 50 manufacturers and work on very different devices, users and use environments.

This diversity of experience allows me to quickly grasp new contexts, identify their specific challenges and apply lessons learned from situations I've already encountered.

The named references presented above correspond exclusively to Usarea engagements. The areas below reflect the experience gained throughout my career as a whole.

Cardiology and cardiac assistance
Diabetes care
Medical imaging
In vitro diagnostics and medical biology
Ophthalmology and eye surgery
Implantable and interventional devices
Medical software, SaMD and remote monitoring
Surgery, anaesthesia and the hospital environment
Treatment administration and preparation
Dental and biomaterials
Women's health
Medicines and health products

This experience covers devices used by patients, caregivers, healthcare professionals, laboratory technicians and hospital teams, in use contexts ranging from the home to the operating room.

ECOSYSTEM

Partners and ecosystem

I have also built collaborations with complementary players in MedTech, quality, regulatory affairs and health innovation.

Logo Eurasanté

I work with start-ups and companies in the Eurasanté ecosystem to support them on their usability challenges.

Logo CSD Med

Usarea and CSD Med combine their expertise on MedTech projects spanning design control, risk management and usability.

Discover the partnership
Logo MedTech France

MedTech France is a media outlet dedicated to the evolution of health innovation and medical technology in France.

Logo QARA Pulse

QARA Pulse offers a software solution dedicated to managing regulatory and quality compliance.

Logo La French Care

I am a member of La French Care, a movement that brings together French health players and showcases their initiatives.

Do you recognise your situation in one of these contexts?

Let's discuss your device, your market and your regulatory constraints.

Let's discuss your project
CE and FDA usability references | Usarea