We take care of your medical software development

With our team of top-notch engineers, your medical software, regardless of its complexity, will meet the highest regulatory requirements and ensure the safety of your patients.

We support you at every stage of your development

Definition & Planning

Great results require solid preparation. We define the requirements, analyze the risks and plan every steps of the development to ensure a safe and efficiently delivered medical software.

 

WE OFFER

 

    • Software development planning
    • System design & architecture
    • Analysis & requirement specifications
    • Risk management & software classification
    • Software project management
Development & Testing

We develop and test embedded medical software , stand-alone medical software as well as mHealth app from class A to C.

 

WE OFFER

 

    • Software & Firmware Engineering
    • System integration
    • Continuous integration
    • Cybersecurity
    • Connectivity
    • Testing
    • Medical Algorithms
    • GUI development
    • Usability

Maintenance & Support

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

 

WE OFFER

 

    • Verification & Validation
    • Technical documentation
    • Regulatory compliance EU & USA
    • Software maintenance and support

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

Collaborative and adaptable approach

To meet your needs & requirements successfully

1.

We listen and discuss to understand your needs and requirements

2.

We plan according to our discussions

3.

We guarantee a fluid transmission of the work completed and a full control of the final result

4.

We develop with regular feedbacks & deliverables

Patient safety is our priority

We develop medical software by applying the following standards

ISO 13485

Medical devices — Quality management systems

ISO 14971

Application of risk management
to medical devices

21 CFR Part 820

Quality System Regulation (FDA)

IEC 62366

Application of usability engineering
to medical devices

IEC 62304

Medical device software — Software life cycle processes

UL 2900

Software cybersecurity
for network-connectable products

Contact us to discuss your needs and future challenges