We help you at all levels of your medical software development to meet the technical, safety and regulatory requirements for CE marking and FDA’s 510(k) approval.
What we offer
Our team of top-notch engineers provides startups and large companies active in the medical sector its know-how in developing medical software to meet the technical, regulatory, safety and security requirements and satisfy the needs of patients, healthcare professionals or other medical users.
We support you at every stage of your development, including definition, development, testing, maintenance and support. Whether it is an embedded or stand-alone medical software or an mHealth app, our team will meet your needs regardless of the classification of your software (from A to C).
Some of our services
- Risk management
- Software classification
- Software & Firmware engineering (stand-alone and embedded systems)
- Cybersecurity
- System and continuous integration
- Verification & validation
Your benefits
By relying on our services, you will reduce the risks and time of your development, ensure a clean & robust coding, high quality documentation and facilitate your certification for EU (CE) and USA (510(k)).
More information on our website.
