Connected healthcare and medical device software
Trakshym builds connected healthcare software for medical device makers, digital health companies and care providers: device connectivity over BLE and Wi-Fi, remote patient monitoring, HL7 FHIR integration with EHRs, and clinical dashboards with alert routing. We build to the requirements of HIPAA and GDPR, working remotely from India for clients worldwide.
What is connected healthcare software?
It links medical devices, patients at home and clinical systems so readings reach the right clinician with context. The usual pieces are a device or gateway app that collects readings, a cloud backend that stores them securely, an integration layer to the EHR, and dashboards that route alerts by threshold.
Edge processing matters for safety and privacy. A phone or bedside gateway can validate readings, buffer them offline and drop data the cloud doesn't need before anything leaves the device.
What does Trakshym build for healthcare and medtech?
Device-to-clinician software with the audit trail, access control and documentation that regulated work needs.
- 01
Medical device connectivity
BLE and Wi-Fi integration with wearables, home monitoring devices and bedside equipment, through companion apps or gateways.
- 02
Remote patient monitoring
Readings collected at home, thresholds set per patient by clinicians, and alerts routed to the responsible care team member.
- 03
EHR integration
HL7 v2 and FHIR interfaces to EHR, lab and scheduling systems so device data lands in the clinical record.
- 04
Clinical and operational dashboards
Patient lists, trends and task queues for care teams; equipment location and utilization for operations.
- 05
Patient and clinician apps
iOS and Android apps with consent, onboarding, reminders and device pairing, designed for older and less technical users.
- 06
Audit, access and data governance
Role-based access, audit logs, encryption in transit and at rest, and retention rules matched to your regulatory obligations.
How do we deliver regulated healthcare software?
Requirements, risks and data flows are written down before code, so the documentation your regulatory team needs is produced as we build.
Regulatory and data mapping
With your regulatory adviser: intended use, classification assumptions, where patient data flows and where it is hosted.
Device integration prototype
One device, one reading path, end to end into a test dashboard, to settle protocol and pairing questions early.
Build with traceability
Features built against written requirements, with test records and change history kept for audit.
Validation support and release
Support for your verification and validation, a controlled release, then monitored operation and maintenance.
- Health data
- HL7 FHIR
- HL7 v2
- SMART on FHIR
- Device side
- BLE
- Wi-Fi
- MQTT
- Companion mobile apps
- Cloud
- AWS
- Azure
- GCP
- Node.js
- Python
- PostgreSQL
- Interfaces
- React
- Next.js
- Flutter
- iOS
- Android
Standards and regulations we build to the requirements of
- HIPAA (US): Privacy and security of protected health information.
- GDPR (EU): Processing of health data as a special category of personal data.
- FDA Software as a Medical Device: When software itself is a medical device in the US.
- IEC 62304: Software lifecycle processes for medical device software.
- ISO 13485: Quality management for medical device manufacturers; we work within your QMS.
- HL7 FHIR: The interoperability standard we use for EHR integration.
What does connected healthcare software cost, and how long does it take?
Regulation sets the pace more than features do. We size it on a discovery call once intended use and classification are clear, and agree a phased plan; no number before that.
Regulatory classification
Software that counts as a medical device needs lifecycle documentation under IEC 62304 and your QMS, which adds defined work to every feature.
Devices and integrations
Each device model and each EHR or lab system adds integration and test effort, plus vendor lead time for test access.
Data protection and hosting
Hosting region, encryption, audit logging and access reviews are built in from the start and sized to your obligations.
Apps and user groups
Patient, clinician and admin apps are separate products with their own usability and accessibility testing.
On a 30-minute call an engineer reviews these drivers with you and tells you what a sensible first phase would include.
Book a discovery callCommon questions about Connected healthcare
Is our software a medical device?
It may be. Software that diagnoses, monitors or informs treatment can count as Software as a Medical Device under FDA and EU MDR rules. That classification is for you and your regulatory adviser to confirm; we then build and document to the requirements it sets, such as IEC 62304 lifecycle records.
How do you handle patient data?
We collect only what the use case needs, encrypt it in transit and at rest, keep it in the hosting region you choose, restrict access by role and log every access. We build to the requirements of HIPAA in the US and GDPR in Europe; formal compliance also depends on your own policies and agreements.
Can you integrate with our EHR?
Yes, through the interfaces the EHR exposes: usually FHIR APIs for newer systems and HL7 v2 messages through an interface engine for older ones. Test environments and access come from the EHR vendor or hospital IT, so we plan that lead time into the schedule.
Which medical devices can you connect?
Devices with BLE, Wi-Fi or a documented API: wearables, blood pressure cuffs, pulse oximeters, glucose meters, scales, and bedside monitors through their gateway or middleware. Devices with proprietary protocols need the manufacturer's SDK or documentation.
How do you avoid alarm fatigue in remote monitoring?
Clinicians set thresholds per patient, repeated alerts are grouped, and each alert goes to one responsible person with escalation if it isn't acknowledged. We review alert volumes with the clinical team during the pilot and tune them before rollout.
Where is patient data hosted?
In the cloud region you choose, usually in the patients' own country or region, on AWS, Azure or Google Cloud under your account. Production access is limited to named engineers who need it, granted by role and logged.
Tell us what's running at your edge.
A 30-minute call with an engineer, not a salesperson. You leave with a scoped next step, whether or not we work together.