Industry · Healthcare & medical devices
Software and firmware built for the rooms where compliance is non-negotiable.
Embedded, mobile and cloud engineering for regulated medical devices and healthcare platforms — with the lifecycle evidence that FDA, EU MDR and PMDA submissions actually need.
Three lanes — one team
A healthcare product is rarely just firmware, just an app or just cloud. We deliver the whole shape from one team.
Embedded for medical devices
FreeRTOS and bare-metal C firmware engineered to IEC 62304 software lifecycle, with risk management traceable to ISO 14971 and documentation for FDA / EU MDR / PMDA submissions.
See capabilityConnected health apps
Patient and clinician-facing iOS and Android apps in Flutter and React Native, with secure pairing to embedded devices and HIPAA / GDPR-aware data flows.
See capabilityCompliant cloud backbone
AWS architectures with HIPAA BAA in place, KMS-backed encryption, IAM least-privilege and audit-ready logging — designed by people who have actually been through audits.
See capabilityFAQ
Healthcare engineering FAQ
Can you take a device through regulatory submission?
We deliver the engineering and the supporting evidence — software requirements, hazard analysis, verification protocols, traceability matrix — that submission consultants and Notified Bodies need. We work alongside your regulatory team rather than replace them.
Do you sign BAAs and DPAs?
Yes. Standard BAAs for HIPAA engagements, DPAs aligned with GDPR / India DPDPA for personal-data processing, and confidentiality terms that survive the engagement.
How do you keep firmware audits clean over time?
Strict version control, signed release branches, configuration-managed toolchains, archived build artefacts, and per-release software documentation packs. A device shipped three years ago can be re-built bit-identical.
Let's build it together
Building a device or a healthcare platform?
We have done it before — firmware, app, cloud and the paper trail. Tell us what you're shipping.