Medical Device Software Development

We build Software as a Medical Device for iOS, Android, and web, covering the full software lifecycle required by IEC 62304. That means a documented Software Requirements Specification, a risk analysis aligned to ISO 14971, a Software Design Specification, and a full set of verification and validation test records that form part of your FDA premarket submission package.

Bluetooth Low Energy pairing with wearable and portable medical devices, cloud data transmission over Wi-Fi and LTE, and over-the-air firmware update management are all standard connectivity patterns we implement. UI design follows FDA human factors guidance so the interface does not introduce use errors that become adverse event reports.

Built for SaMD startups preparing for FDA 510(k) or De Novo submission, medical device makers adding a regulated software companion to an existing hardware product, and digital therapeutics companies building prescription software.

We build the backend infrastructure that receives telemetry from medical devices at scale. That means AWS IoT Core, Azure IoT Hub, or Google Cloud IoT for device connectivity, plus data storage configured for HIPAA-grade access controls with encryption at rest. Role-based access controls and a complete audit log cover every data access and modification.

Data ingestion handles continuous streams from wearable sensors and periodic batch uploads from portable devices. Configurable alert rules fire when readings cross clinical thresholds, routing notifications to the appropriate clinical user. Time-series data is stored in a format that supports both real-time dashboards and retrospective clinical reporting.

Built for health monitoring device makers without an existing data backend, RPM program operators replacing manual data review processes, and digital health companies connecting multiple device types to a single data platform.

We build clinician-facing RPM dashboards that aggregate patient data from connected devices, display readings against configurable clinical thresholds, and route alerts to the responsible care team member without a manual triage step. Patient list views, individual patient timelines, reading trend charts, and alert acknowledgment workflows are all part of the standard interface pattern.

Patient-facing companion apps display readings back to the patient with education content, medication reminders, and symptom logging. Secure messaging between patient and care team reduces phone call volume. Medicare's RPM CPT codes reimburse care-management time, so the workflow also captures the device readings and clinician minutes a reimbursement claim has to document.

Built for RPM program operators scaling past what spreadsheet-based review can handle, health systems building an in-house RPM capability, and device companies that need a clinical interface to accompany their device in hospital procurement conversations.

We build clinical data management platforms that collect structured data from medical devices, clinical staff, and patient-reported outcomes. The data sits in an environment configured for HIPAA-grade access controls with full audit logging, and is made available to the right user through role-based access controls. Each data field is timestamped and attributed to its source, and every access event is logged. Modifications are versioned, so the history is always recoverable.

Configurable data collection forms handle device onboarding, clinical assessments, and adverse event reporting. Reporting tools export data in formats compatible with FDA postmarket surveillance requirements and IRB-defined clinical study protocols. Integration with existing EHR platforms via FHIR R4 or HL7 v2 keeps the clinical record current without duplicate data entry.

Built for clinical research organizations managing device study data, health systems running postmarket surveillance programs, and medical device companies building the data infrastructure needed for FDA 522 postmarket study obligations.

We build the integration layer between medical device data and the EHR systems hospital IT teams will accept. Device telemetry is transformed into FHIR R4 Observation, DiagnosticReport, or DeviceMetric resources for systems running Epic's FHIR API or Cerner Millennium. HL7 v2 ORU interfaces handle legacy integration requirements at health systems that have not yet migrated to FHIR. DICOM integration handles imaging-adjacent device data.

SMART on FHIR enables your application to launch in-context within the Epic or Cerner clinical workflow, so clinicians access device data without switching systems. Bi-directional interfaces support result acknowledgment and order-driven device activation workflows. Every integration is scoped against the specific EHR version and site configuration rather than a generic specification.

Built for medical device companies whose hospital sales are blocked by missing EHR integration, digital health startups building SMART on FHIR applications for Epic App Orchard, and RPM operators whose device data needs to land in the patient record automatically.

We produce the software documentation package that FDA premarket submissions require. That includes a Software Requirements Specification that maps to the IEC 62304 software safety class, a risk analysis in ISO 14971 format, a Software Design Specification with architecture diagrams, and a verification and validation test report covering unit, integration, and system testing. A Software Bill of Materials satisfies the FDA's cybersecurity documentation requirement for connected devices.

Change control documentation covers every post-release modification with an assessment of safety impact, updated risk analysis, and regression test evidence. Postmarket cybersecurity monitoring includes a vulnerability management plan and a defined process for issuing patches within the FDA's expected response timeframes for the device's risk class.

Built for medical device startups preparing their first 510(k) or De Novo submission, and for established device companies adding SaMD to an existing hardware submission. Quality teams get compliant documentation produced as a standard output, not an afterthought.