Software as a Medical Device isn't just a classification. It's an entirely different engineering discipline. We architect SaMD products with IEC 62304 compliance, human factors engineering per IEC 62366, risk management documentation per ISO 14971, and FDA pre-submission alignment built into the process from week one. Your Design History File isn't an afterthought. It's how we work.
For MedTech startups pursuing FDA clearance or CE marking on software-driven products
The software inside your device determines whether it gets cleared, adopted and trusted in clinical settings. We engineer firmware, embedded software and companion applications for connected medical devices where every release cycle carries regulatory consequences. Design controls, software of unknown provenance reviews, verification and validation. Done as part of the build, not bolted on before submission.
For Device manufacturers who need a software partner that understands the hardware it runs on
We develop AI systems that operate inside regulated medical environments. Diagnostic imaging analysis, clinical decision support, anomaly detection, predictive risk models. Built with algorithm change protocols, validation frameworks and audit trails that FDA and clinical governance teams require. Not prototypes. Production systems with a regulatory pathway from day one.
For AI MedTech startups and product teams commercializing clinical intelligence
Through IntelliXR, our extended reality platform purpose-built for healthcare, we develop XR applications for surgical simulation, clinical training, vision diagnostics, therapeutic rehabilitation and patient engagement. Human factors validation, clinical workflow integration and device-level compliance are built into every XR product we ship. These aren't immersive demos. They're regulated, deployable clinical tools.
For Healthcare innovators using VR, AR or mixed reality in clinical or therapeutic settings
Not every healthcare product is a medical device. But every healthcare software product carries clinical, compliance and user experience obligations that generic software shops aren't equipped to handle. We engineer custom healthcare software for clinical workflows, provider operations, patient engagement and care coordination. HIPAA-compliant architecture, clinical UX grounded in human factors principles and software that works the way clinicians and patients actually work.
For Product teams building clinical software, provider tools and patient facing healthcare applications
We engineer digital health platforms that operate across patient, provider and device layers simultaneously. Remote patient monitoring, chronic care management, virtual care infrastructure, population health and connected health ecosystems. Every platform is HIPAA-compliant, audit-ready and stress-tested for real patient volume before it goes anywhere near a clinical environment.
For Digital health companies moving from early product to clinical deployment at scale
Wearable medical devices live at the intersection of hardware, connectivity and clinical data. We handle the full software stack. Firmware, BLE and wireless protocols, companion mobile applications, real-time cloud data pipelines and device management infrastructure. Usability engineering and human factors validation included. Built for FDA and CE regulated environments from the ground up.
For IoT and connected device companies who need one engineering partner across the full stack
DTx products face a uniquely difficult challenge. They need to meet clinical evidence standards, pass regulatory scrutiny and still deliver an experience patients actually use. We develop prescription digital therapeutics, biofeedback platforms and rehabilitation technology with human factors engineering, clinical validation protocols and the regulatory depth both requirements demand.
For Therapeutics and rehabilitation technology companies pursuing regulatory approval and clinical adoption
Not a service catalogue. These are the exact engagements we run for MedTech and HealthTech product teams right now.
