We do not issue certifications ourselves, but we build products in line with ISO 13485 and IEC 62304 and deliver the technical file content (risk management, software architecture, verification and validation evidence) that notified bodies and the FDA expect. We work alongside your regulatory consultant or notified body

A clinical-grade healthcare app typically ranges from a multi-week prototype to a multi-month regulated product build, depending on whether it qualifies as a medical device. Cost is driven by signal complexity, regulatory scope (CE, FDA), and integration requirements. A short discovery call lets us give a realistic range for your specific case.

We work with EEG, ECG, PPG, respiratory, accelerometry, temperature, and imaging data, as well as patient-reported outcomes and electronic health record (EHR) feeds. Projects include sleep monitoring, cardiac event detection, and remote patient monitoring for chronic-disease care.

Sentigrate’s healthcare software development covers connected medical devices, biosignal processing, clinical dashboards, patient-facing mobile apps, and backend platforms that integrate with hospital and research systems. We align with ISO 13485 and IEC 62304 quality practices and support clients through CE-marking documentation when the product is a medical device