Our Services

MedTech compliance

We build and refine quality-system documentation and development workflows that meet ISO 13485 and FDA QMSR (21 CFR 820), and implement 21 CFR Part 11 controls for electronic records/signatures.

Signals & sensors

Expertise with signal processing allows us to extract valuable information from a wide variety of data sources and indicators. From sensors to biomarkers, we can leverage algorithms using prior knowledge of the sensor characteristics.

Biotech data

We excel at biological domains, including genomics, metabolomics, proteomics, synthetic biology, computational chemistry for drug discovery, disease diagnostics, and clinical trial analysis. We are familiar with medical regulations and norms (ISO 13485, 21 CFR).

Embedded systems & IoT

IoT-based embedded system can go beyond monitoring and control. AI enables IoT networks and fleets with data-driven operations.

DevOps and cloud

Deploy hybrid self-hosted/cloud solutions that allow efficient data acquisition and processing while complementing practical decision-making tools.

Security

We design and operationalise risk-based ISMS programs aligned to ISO/IEC 27001, make you “NIS2-ready” (essential measures, supplier risk, monitoring, incident handling), and embed GDPR-by-design.

Have a project in mind? Let’s get to work.