User-centric solutions for MDR compliance

Usability Engineering for Medical Devices

At Milani, we focus on user-centered usability engineering solutions for medical devices. Our experts work closely with design and development teams to ensure that your medical devices not only comply with regulatory requirements such as MDR and IEC 62366-1, but also provide a positive user experience.

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Benefits of integrating usability into the design process

Regulatory compliance

We help you meet regulatory requirements such as the Medical Device Directive (MDR) and IEC 62366-1.

Make confident decisions through usability testing

With objective data and usability testing, you can make informed product decisions and avoid costly mistakes.

Minimize risk

Early identification of user errors supports risk management and improves the safety of your products.

Customer retention through a positive user experience

A superior user experience increases customer satisfaction and loyalty.

Our usability engineering services at a glance

Integrating usability into the development process

From the initial idea to the market launch, we accompany your project with sophisticated usability methods to ensure that your product is optimally tailored to the needs of the user.

User Research & Context Analysis

By analyzing the context of use, you gain valuable insights into the needs of your target group, which serve as a basis for product development.

Formative & Summative Evaluations

Continuously test your product during development and before launch to ensure it meets all requirements.

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Problems identified through usability research - effective solutions through design

At Milani, usability and design go hand in hand. Our usability team identifies weaknesses in your medical products early on, while our design team develops solutions that are both functional and aesthetically pleasing. The success of this process is based on a clear understanding of user needs from the outset.

Our projects often begin with extensive user research and contextual analysis to pinpoint the underlying challenges. This user-centered approach is at the heart of our usability engineering proce

Through ongoing usability assessments and formative evaluations, we identify obstacles at all levels early on - both superficial and deep. These continuous usability assessments are an integral part of the product development process and ensure that identified problems are incorporated directly into the design.

The result: a design that not only significantly improves the usability and efficiency of a product, but also meets the regulatory requirements of the Medical Device Regulation (MDR) and IEC 62366-1. In this way, every product becomes a harmonious combination of innovation, functionality and aesthetics.

Get in touch!

Peter Kancsár
Lead CX/UX/UI, Member of the Board
welcome@milani.ch
+41 44 914 74 74