Your one-stop Partner for user-centered Medical Products.

We design innovative medical devices that are safe & intuitive to use.

Lukas Wittwer | Managing Director Austria & Germany

Medical products are becoming increasingly connected, digital – and subject to complex global regulations. Consulteer is your one-stop partner for user-centered product development – from early user research through design, engineering, regulatory approval, and post-market surveillance.

With over 15 years of experience, we combine human-centered design, software engineering, industrial design, and regulatory expertise into a clearly structured development process – delivering solutions that are safe, intuitive, and compliant across international markets.

• Digital & Physical Products

• MDR & FDA Compliant

• ISO 13485 / ISO 14971 / IEC 62304 / IEC 62366-1

Our Service Portfolio.

Human-Centered Design

Software Development & Systemintegration

Regulatory Affairs & Validation

Cybersecurity & Lifecycle Support

Usability Engineering.

Whether it's a surgical assistance system or a home diagnostic device, every successful medical technology project begins with a deep understanding of the context of use, the target users and the regulatory requirements.

Our structured usability process integrates the following from the outset:

• Human-centred design in accordance with ISO 9241-210

• Use-related risk analysis in accordance with ISO 14971

• Usability engineering in accordance with IEC 62366-1

We accompany you from the use specification through formative and summative evaluations in the clinical environment to compliant documentation – so that your product not only works, but is also safe, usable and marketable.

Medical Devices & Software Solutions.

As medical products become increasingly digital, the demands for interoperability, cybersecurity, and intuitive use continue to grow. We design and implement connected digital solutions such as:

• Embedded systems

• Mobile health apps

• Cloud-based platforms and portals

By integrating UX design, software engineering, and cybersecurity, we create systems that meet both regulatory requirements and usability goals.

Trusted Partnerships.

Why Consulteer?

• Deep expertise & regulatory clarity: ISO 13485, ISO 14971, IEC 62366-1, IEC 62304

• Trusted by leading innovators: Leica Microsystems, VirtaMed, OCULUS, Fette Compacting, Vitagroup

• Interdisciplinary teams: Engineering, design & regulatory under one roof

• Full-service delivery: From user research to regulatory submission

• Product development with accountability: With usability and patient safety at the core

Together, we design safe medical products.

You’re developing a new medical product – physical, digital, or hybrid – or planning to elevate an existing system to MDR or FDA compliance?

As an interdisciplinary partner, we support you across the entire product development lifecycle: from user-driven requirements and human-centered design to usability engineering, software development, regulatory documentation, and post-market surveillance.

Whether you’re a startup, SME, or global enterprise – we combine methodological depth with practical execution. This is how we guide your medical product to a safe, efficient, and compliant market launch.