Software for Medical Equipment & SaMD
IEC 62304–aligned development, device cloud connectivity, interoperability, and cybersecurity for diagnostic and therapeutic equipment — built for FDA-aware quality systems.
We build solutions using leading technologies like
Build Regulated MedTech Software
Device makers need software that satisfies design controls, cybersecurity expectations, and hospital interoperability — without slowing release velocity or traceability.
We engineer SaMD companions, device clouds, and integration layers aligned to your QMS, with evidence-ready SDLC artifacts and secure connectivity to clinical environments.
SaMD & UX
Companion apps and clinician workflows with audit logs and role-based access
Device Cloud
Telemetry, fleet health, and remote diagnostics with high-assurance pipelines
Interoperability
HL7 FHIR, DICOM, and hospital ADT patterns with monitored interfaces
Cyber & OTA
SBOM-aware builds, secure updates, and threat modeling for connected devices
MedTech Capabilities
From design controls to post-market — software built for regulated devices.
SaMD & Companion Apps
Mobile and web companions for diagnostics and therapeutics with offline modes, audit trails, and clinical role models.
Device Cloud & Telemetry
High-assurance ingestion, time-series storage, and fleet dashboards for utilization, errors, and remote diagnostics.
Interoperability
HL7 FHIR, DICOM, and hospital IT integration with test harnesses and interface monitoring.
Cybersecurity for Devices
Threat modeling, SBOM generation, secure boot consultation, and FDA cybersecurity guidance alignment.
QMS & Validation
CSV packages, IQ/OQ support artifacts, and traceability from requirements to verified results.
AI/ML on Device Data
Clinical decision support workflows, model monitoring, and drift detection with governance for regulated ML.
Stacks We Engineer On
Cloud, data, and identity platforms common in regulated MedTech delivery.
AWS Health
GCP
Kubernetes
Okta
GitLab / GitHub
Snowflake
Kafka
TerraformEngagement Model
Discovery through hypercare — with evidence and security baked in.
Product & Risk Discovery
Intended use, SOUP inventory, threat modeling, and integration landscape
Week 1–2Architecture & SDLC
Software plan, verification strategy, cybersecurity architecture, and release train
Week 3–4Build & Verify
Iterative delivery with traceable requirements, tests, and release documentation
Week 5–16Post-Market & Sustain
Monitoring, CAPA hooks, OTA discipline, and roadmap for next releases
OngoingWhy Leaders Choose Us for MedTech
Regulated Delivery
Teams experienced with design controls, SOUP, and audit-ready artifacts.
Security & Privacy
SOC 2 patterns, HIPAA-aware builds, and least-privilege access by default.
Hospital-Ready Interop
FHIR and DICOM expertise so devices fit real clinical IT environments.
Clinician-Centered UX
Workflows tuned for busy care settings with accessibility in mind.
Fleet Intelligence
Telemetry and reliability metrics product and service teams can act on.
Lifecycle Partner
Ongoing releases, cybersecurity updates, and platform evolution after launch.
Diagnostic OEM Shipped SaMD Companion with Full Traceability in Nine Months
We delivered a regulated mobile companion, device cloud ingestion, and FHIR export — with requirements-to-test traceability and cybersecurity documentation aligned to the customer QMS.
Frequently Asked Questions
Answers for technology and procurement leaders in this sector. Need more detail? Our architects are ready.
Ask Our ExpertsReady to Ship Connected MedTech?
Book a session with our MedTech architects — architecture and SDLC plan tailored to your device class.