Onext delivers secure, HIPAA and ISO-certified healthcare software solutions for medical providers, healthtech startups, and payers across the US, EU, UK, Australia, and Singapore.
Globally certified, AI-augmented devs
A decade and a half of expertise
98% Client Retention Rate
We are a trusted healthcare software partner certified in ISO 9001/27001. We ensure accurate compliance, perform thorough integration audits before quoting, and guarantee uninterrupted clinical continuity to maximize cost efficiency.
How Healthcare Software Development WorksOur team delivers secure, interoperable medical software across the US, EU, APAC, and Singapore with full HIPAA and ISO-certified security standards.
We accelerate product launches through 2-week Agile sprints and DevOps pipelines, managing risks effectively through rapid, iterative deployments.
Our engineering teams integrate AI capabilities, cloud infrastructure, and modern healthtech protocols to build resilient, future-proof medical platform
We ensure your medical software adheres to global regulatory frameworks, protecting patient data and maintaining complete privacy.
HIPAA protects patient medical data privacy. We implement continuous monitoring, employee training, and security audits to keep your software fully compliant.
GDPR governs individual data privacy within the EU and EEA. Our architecture enforces strict user consent, data residency, and encrypted cross-border storage.
The HITECH Act strengthens HIPAA enforcement and promotes EHR adoption. We build secure FHIR/HL7 interfaces that expand record access safely.
FDA rules ensure safety and quality for medical products and software. We engineer platforms meeting rigorous clinical and operational standards.
Most clients start with one and grow into the others as the business does. Every engagement draws on the same delivery team.
Building intuitive patient portals, clinical dashboards, and custom EHR/EMR extensions engineered for streamlined workflows and strict HIPAA compliance.
Seamless system integration connecting clinical environments, medical devices, and third-party software using global healthcare standards like HL7, FHIR, and DICOM.
Enterprise-grade data security management built into the core architecture to ensure full alignment with HIPAA, GDPR, MDR, and ISO 27001 requirements.
Transforming fragmented medical records into actionable clinical insights through real-time data pipelines, population health monitoring, and BI reporting.
A streamlined development framework ensuring total transparency and alignment with your healthcare goals from start to support.
A call to align on clinical goals, compliance requirements, timelines, and define where custom healthcare software adds value.
We map clinical workflows and integrations, then deliver a documented SRS, compliance risk plan, and a precise project estimate.
A dedicated healthtech team is assigned, NDAs signed, security controls set up, and access configured in your development tools.
Short Agile sprints with regular demos, secure coding, medical QA testing, and UX design focused on real clinical workflows.
Staged deployment, data migration, security monitoring, and ongoing maintenance to keep systems stable and fully compliant
Pick the model that fits how your team is set up. Many clients start with one project, then move to a dedicated team.
Our engineers work as yours, embedded in your stand-ups and board, scaling up or down month to month.
We deliver under your brand. Your client sees your agency; we stay invisible behind the NDA.
A defined build with a fixed scope, timeline and price, handed over complete with documentation.
We match the stack to the problem rather than forcing one framework onto every project.
We apply emerging technology responsibly, only where it reduces risk, optimizes operations, or improves clinical outcomes.
Use AI to support clinical decisions, automate routine tasks, and reduce administrative workload.
Connect medical devices and wearables to monitor patients remotely and provide real-time health data.
Connect and manage healthcare data securely across systems, locations, and care teams using HL7 and FHIR.
Explore the response to frequently asked questions to find the information you’re looking for.
Frequently you should buy, and we will tell you when. Custom software is defensible when your service model does not fit standard templates, when product integration is the main gap, or when your scale makes licensing costs strategic.
We assess all interfaces before quoting because interoperability is core to healthcare projects. We connect systems using HL7, FHIR, DICOM, and direct database integrations, leading the timeline with integration work when necessary.
Project costs range from $30,000 for an MVP to $300,000+ for enterprise platforms. With Onext's delivery center in Vietnam, you capture a clear cost advantage with rates starting from $20/hour, without compromising US-grade quality or compliance.
Yes, we develop medical device software (FDA classes II and III, IEC 62304) and SaMD with full documentation, design controls, and verification processes aligned with the FDA 510(k) program.