You imagine, we develop. 

With our team of experts engineers, we take care of your medical device development, regardless of its complexity. We will meet the highest regulatory requirements and ensure the safety of your patients.

We support you at every stage of your development

Hardware Engineering

Great results require great people. Our engineers are experts in the development of electro-mechanical medical devices.

 

WE OFFER

 

    • 3D Modelling, prototyping, mechanical simulations, 
    • Tolerance analysis, 
    • PCB design and routing, 
    • Mechanics and mechatronics engineering, 
    • Micro-mechanics and electro-mechanics engineering, 
    • Complex fluidics and micro fluidics engineering, 
    • Definition of quality criteria and controls, 
    • Design for Manufacturing  
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Software Engineering

We provide software design, development, and verification services. We undertake all essential development support activities to meet regulatory requirements and facilitate the release, certification, and maintenance of your software.  

 

WE OFFER

 

    • Firmware / Embedded software 
    • SaMD from Class A to C (mobile apps, web apps, backend) 
    • Connectivity  
    • Cybersecurity 
    • Machine learning (AI) 
    • GUI development with selected partners 
Reference

System Engineering

Developing a Medical Device relies on well-defined requirements, deep risk analysis and step-by-step plans of the development to ensure a safe and efficient delivered medical device. We ensure project coordination between all team members.

 

WE OFFER

 

    • Project coordination and management 
    • Usability engineering 
    • Feature’s integration 
    • Design control and corresponding technical documentation 
    • Verification & Validation 
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Patient safety through strict regulatory compliance

Facilitating the homologation process of your medical device and supporting your claims of compliance with the competent entities both in the EU & the US.

WE COMPLY WITH

  • MDR and GDPR,
  • FDA CFR 21 Part 820 and HIPAA,
  • ISO 13485 & 14971, IEC 62366,
  • IEC 62304, 60601 Series, 10993 Series & 82304 Series,
  • UL-2900 Series.

 

 

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Your benefits

Reduced development time

Shorter
time-to-market
Reduced development risks
Clean & robust coding
Facilitated certification for EU and USA
Access to Swiss Health Valley network

Patient safety is our priority

We develop your medical devices in accordance with the following standards.

Let us know how we can support you.

Send us your request