Software is the product
SaMD, software-driven devices, and digital therapeutics are the fastest-growing submissions. The clinical value lives in algorithms, apps, and cloud services—and so does the regulatory scrutiny.
Healthcare software that clears review and keeps patients safe
Stackera designs, builds, secures, and operates software for hospitals, pharmacies, healthcare logistics, and digital health—clinical platforms, vaccine and medicines cold-chain tracking, remote monitoring, SaMD, and FHIR interoperability—with privacy, GDP/GxP controls, and evidence built into delivery so regulatory review is a checkpoint, not a rewrite.
What's happening in Healthcare
Software now decides whether care is safe, medicines arrive intact, and products get to market. Regulators, hospitals, and payers have all raised the bar on evidence, interoperability, traceability, and cybersecurity at the same time.
Cold chain is a data problem
Vaccines and temperature-sensitive medicines demand continuous monitoring, calibrated sensors, and GDP-compliant audit trails. A missing temperature record is a discarded batch.
Traceability is expected end to end
RFID and barcode tracking from licensed store to ward or pharmacy shelf is becoming the baseline for recalls, stock accuracy, and proof of custody.
Interoperability is mandated
FHIR APIs, information-blocking rules, and payer data-exchange requirements mean a product that can't exchange records with EHRs and payers is a product hospitals can't buy.
Care moves home
Remote monitoring, hospital-at-home, and digital therapeutics shift the product surface to consumer devices and cloud—where reliability, privacy, and usability decide adoption.
Cybersecurity is a review requirement
Threat models, SBOMs, PHI controls, and vulnerability plans are now part of device submissions and hospital procurement alike. No security story, no market.
The problems healthcare teams are facing
The gap between a working system and one that clears review, connects to hospital systems, proves custody of every dose, and holds patient trust shows up in documentation, validation, data flow, security, and the cost of change.
Temperature logs, delivery records, design controls, and audit trails are reconstructed from spreadsheets and tickets when an inspector or reviewer asks. Gaps surface in review, and every finding becomes a rework loop.
Platforms we deliver
Each platform starts from the intended use, the risk classification, and the chain of custody—then adds the data model, integrations, and controls the product needs to be safe, compliant, and deployable.
Clinical & Pharmacy Platforms
Ordering, dispensing, stock management, and replenishment workflows for hospitals, pharmacies, and distributors—with RFID and barcode traceability from receipt to administration.
- RFID stock management
- Scheduled replenishment
- Recall traceability
Cold-Chain & Delivery Tracking
Vaccine and medicines logistics with continuous temperature monitoring, calibrated sensors, route and delivery tracking, and GDP-compliant records generated automatically.
- Continuous temperature logs
- Delivery tracking
- GDP audit trails
Clinical Data & Interoperability
FHIR-native data platforms, HL7 and DICOM integration, identity and consent management, and EHR connectivity that make deployment repeatable across health systems.
- FHIR APIs
- EHR integration
- Consent management
Remote Monitoring & Digital Health
Patient-facing apps, clinician dashboards, alerting, and engagement workflows for remote monitoring, hospital-at-home, and digital therapeutics.
- Patient apps
- Clinician workflows
- Alert prioritisation
SaMD & Connected Devices
Diagnostic, decision-support, and device-companion software built under IEC 62304 lifecycle processes with risk management, usability engineering, and traceable verification.
- IEC 62304 lifecycle
- Device connectivity
- Algorithm validation
We design, build, and support healthcare platforms
From clinical workflows and pharmacy operations to connected devices and patient apps, we build the software, integrations, and data systems your healthcare platform needs.
Clinical Workflow Software
Patient intake, appointment scheduling, care-team task management, and clinical documentation connected to hospital systems
Pharmacy & Inventory Management
Medicine ordering, dispensing, stock tracking, and replenishment with barcode and RFID traceability
Cold-Chain & Delivery Tracking
Temperature sensor integrations, excursion alerts, shipment tracking, and delivery records for medicines and vaccines
EHR & Health Data Integration
FHIR APIs, HL7 messaging, and DICOM integrations that connect patient records, clinical systems, and imaging workflows
Patient Apps & Remote Monitoring
Patient portals, device readings, symptom check-ins, and clinician dashboards with configurable alerts and follow-up workflows
Medical Device Software
Device connectivity, companion applications, and diagnostic and decision-support workflows with traceable requirements and verification
Health Data Privacy & Consent
Role-based access, patient consent workflows, data de-identification, and audit trails for sensitive health information
Healthcare Analytics & Reporting
Clinical operations, medicine stock, temperature, and delivery dashboards with reporting workflows for quality and oversight teams
The right engagement for your next healthcare product
Start with a defined build, extend your team, or take over an existing platform. We agree the scope, success measures, and ownership before delivery begins.
Fixed-Scope Build
A focused clinical, pharmacy, or care operations product delivered against an agreed specification, integration plan, and acceptance criteria.
Best for: Teams launching a defined healthcare product with a clear business outcome.
4–8 weeks
Dedicated Team
An embedded team that brings product, data, and security engineering into your roadmap, with attention to clinical workflows, data access, and quality requirements.
Best for: Organizations expanding their platform with an ongoing product and engineering roadmap.
Team embedded in 3 days
AI-Inclusive Build
Add clinical documentation, triage, or demand planning assistance to your product with trusted data, evaluation criteria, and human review built in.
Best for: Teams adding intelligent assistance to workflows their customers and operators already use.
Scoped
Existing Platform Takeover
Take ownership of an existing platform, review patient data flows, access controls, and product documentation, and prioritize the improvements needed for dependable production use.
Best for: Teams inheriting a codebase or moving beyond their original delivery partner.
Platform takeover in 3 days
How Delivery Runs
- 1 week
Discovery & Architecture
Define intended use, data boundaries, and validation criteria, then agree the architecture, delivery scope, and measures of success.
- 4–6 weeks
Build & Launch
Deliver working increments with workflow testing, traceable requirements, and release review. Prepare the team and production environment before release.
- Ongoing
Operate & Improve
Monitor service quality, user feedback, and evolving clinical workflows. Maintain tests and improve the platform as requirements evolve.
Not sure which model fits?
Start with a discovery sprint to assess your clinical workflow, data needs, and validation requirements, then define a practical path to production.
Why Stackera Is
The Right Partner
+10 Years Of Experience
Temperature records, audit trails, requirements, and verification evidence are produced by how we build, not assembled afterwards—so the file an inspector sees reflects the system that actually runs.
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