Healthcare platforms built by a team that's navigated FDA clearance.

Our team has shipped FDA-regulated medical devices from clinical validation through market clearance. We build AI-powered clinical decision support, FHIR/HL7 integrations, SaMD architectures, remote patient monitoring platforms, and the clinical data pipelines that connect devices to health systems. AI is transforming healthcare — but only if it's built with compliance embedded from day one.

Sound Familiar?

Problems we solve

Your clinical device is designed, but FDA Class II regulation is a legal minefield you haven't navigated before.

You need to integrate patient data into EHR systems, but FHIR/HL7 implementation is months behind schedule.

Your remote monitoring system reduces documentation time by 30%, but you can't prove it because your data pipelines are fragmented.

Translating validation protocols into regulatory submissions is consuming your entire technical team.

Your patient portal was supposed to ship last quarter, but your EHR integration keeps breaking on edge cases your vendor hasn't seen before.

Your compliance team reviews every release manually because audit trail requirements weren't built into the architecture — and every release cycle takes twice as long as it should.

Capabilities

What we build

FDA-Regulated Medical Device Development

Design history files, clinical validation data, 21 CFR Part 11 controls, and traceability matrices — built for FDA Class II clearance from prototype through submission.

FDA Class II clearance requires a design history file, clinical validation data, and 21 CFR Part 11 evidence of system controls. Our team has managed the full lifecycle from prototype through FDA submission. We know what regulators want to see: traceability matrices, design specifications tied to requirements, and validation protocols proving the device does what you claim.

FHIR/HL7 Integration & Health System Connectivity

Clinical data integration with major EHR systems via FHIR and HL7 protocols — starting with the clinical workflow, not just the API spec.

Healthcare data integration isn't just a technical problem — it's a clinical one. We integrate with major EHR systems via FHIR and HL7 protocols, starting with the clinical workflow. We've built these integrations through interoperability platforms, meaning your data reaches hospitals through trusted, HIPAA-compliant channels.

AI Clinical Decision Support & Evidence Generation

AI-powered clinical analytics, risk scoring models, and evidence databases that generate clinically valid, traceable proof of your device's performance claims.

AI is transforming clinical workflows — patient risk scoring, diagnostic pattern recognition, treatment recommendation engines, and clinical documentation automation. But AI in healthcare only matters if it's clinically valid and traceable. We build the AI models, validation protocols, and evidence databases that let you deploy clinical intelligence with the regulatory rigor the FDA expects.

Remote Patient Monitoring & Telemedicine

RPM and telehealth platforms that capture data to CMS reimbursement standards — documented, auditable, and integrated with EHR systems.

RPM and telehealth are reimbursable, but only if data is captured according to CMS requirements and documented in a way that survives audits. We build AI-enhanced systems that pull vital signs from medical devices, apply risk scoring models to flag deteriorating patients before clinical events, present them to clinicians in real time, and integrate with EHR systems so the interaction becomes part of the patient's legal medical record.

AI/ML SaMD (Software as a Medical Device) Architecture

Regulatory-ready architecture for AI-powered clinical software — model validation, version control, algorithm documentation, audit trails, and clinical safety evidence from day one.

If your AI algorithm influences clinical decisions, it's likely SaMD — and the FDA is paying close attention. We help you architect AI-powered medical software for regulatory success from the start: model versioning and traceability, documented validation of ML algorithms against clinical datasets, clear audit trails of model updates, and evidence of clinical safety. As the FDA evolves its framework for AI/ML-based SaMD, your architecture is already built for it.

Patient Portal & Clinical Workflow Tools

Custom patient-facing portals and clinician workflow tools — appointment scheduling, secure messaging, care plan tracking, and medication management.

Health systems and digital health companies need tools that fit their specific clinical workflows — not the generic modules that ship with enterprise systems. We build patient portals with secure messaging, appointment scheduling, care plan management, and medication tracking. Designed for the specific clinical context, integrated with your existing health system infrastructure.

The Difference

Why AppAxis

FDA-Regulated Device Experience

Our team has taken medical devices from clinical validation through FDA Class II clearance. Design controls, clinical validation protocols, regulatory submissions, 21 CFR Part 11 evidence — this isn't theoretical compliance knowledge. It's production experience with real regulatory outcomes.

Compliance Embedded from Day One

Most development teams bolt compliance onto a finished product. We design regulatory and clinical requirements into the architecture from the first week. 21 CFR Part 11 controls, HIPAA safeguards, and audit trail requirements aren't afterthoughts — they're structural decisions that shape the codebase.

You Own the Code

Healthcare SaaS vendors charge per-provider, per-month. We build on your infrastructure, deliver your source code, and transfer full ownership. Your clinical platform scales with your patient volume, not your vendor's invoice. Full documentation, no lock-in.

EHR Integration Expertise

We don't compete with EHR systems — we build the clinical tools and data integrations that extend them. Our team integrates with major EHR platforms via FHIR and HL7 protocols, using interoperability middleware that ensures your data reaches health systems through trusted, HIPAA-compliant channels.

Scenario

FDA-Regulated Wearable Device

Challenge

A healthcare startup needed to take a senior safety wearable from concept through FDA Class II clearance with limited engineering resources.

Solution

Our team managed the full product lifecycle — design controls, clinical validation protocols, regulatory submissions, and FHIR integration with hospital systems.

Result

FDA Class II clearance achieved. Product shipped to market with full regulatory compliance documentation.

Our Approach

How we work with healthcare companies

Assessment

We start by understanding your clinical and regulatory context — what you're building, where you are in the FDA pathway, which health systems you need to integrate with, and what compliance requirements apply. We map the technical architecture against the regulatory landscape so nothing gets bolted on later.

Proposaltype

We deliver an interactive prototype built around your actual clinical workflow — not a generic wireframe. You see how patient data flows, how the EHR integration handles your specific environment, how compliance controls are embedded in the architecture. Your clinical and regulatory teams review it before you commit to a full build.

Weekly Showbacks

During the build, your clinical team, your regulatory team, and your leadership see working progress every week. Real patient data flows (de-identified in staging), real EHR integration touchpoints, real compliance documentation generated alongside the code.

Learn more about our process

Explore

Your healthcare technology deserves a team that's shipped FDA-cleared devices.

Whether you're navigating FDA clearance, building FHIR integrations, or developing remote monitoring platforms — we've been through it before.