We build medical device software that meets FDA, HIPAA, and IEC 62304 requirements from day one. Whether you are developing a diagnostic tool, a wearable monitor, an AI-powered imaging solution, or a connected IoMT platform, we embed compliance, security, and clinical performance into every layer of the software.
HIPAA Compliant
HL7 / FHIR Compatible
SOC 2 Type II
Trusted by industry leaders
Certifications and Accreditations
Medical device software operates in an environment where a bug is not just a bug. It is a patient safety issue, a regulatory event, or a recall. Our clients understand that. They come to us because they need a development partner who treats compliance as a foundation, not an afterthought.
A medical device manufacturer building or modernizing embedded device software
A digital health startup developing a Software as a Medical Device (SaMD) product that requires FDA 510(k) clearance or CE marking
A hospital or health system integrating custom software with your medical devices, EHR systems, and clinical workflows
A MedTech product team that needs to augment your engineering capacity with healthcare software specialists
A Chief Technology Officer or Founder who needs a development partner that can own both the technical delivery and the regulatory documentation 
Every service we offer is designed for one outcome: medical device software that performs correctly under clinical conditions, survives regulatory review, and scales with your product roadmap.
We design and build device-specific software tailored to your hardware and clinical use case. From embedded firmware interfaces to clinical dashboards, every component is built for accuracy, reliability, and regulatory traceability. Whether your device handles diagnostics, therapy delivery, monitoring, or imaging, the software we build matches the safety class of the device it runs on.
We integrate AI and ML capabilities into medical device software to power smart diagnostics, anomaly detection, predictive maintenance, and clinical decision support. Our AI models are built with validation and verification documentation aligned to FDA guidance on AI-enabled devices, so your software is not just intelligent but audit-ready. This includes computer vision for imaging, NLP for clinical documentation, and predictive analytics for patient risk stratification.
We build the connectivity layer that makes your medical devices talk to each other and to clinical systems. This includes real-time data sync with IoMT platforms, Bluetooth Low Energy (BLE), Wi-Fi, and cellular communication, and full compliance with interoperability standards including HL7 v2/v3, FHIR R4, DICOM, and IHE profiles. Our IoMT software development work enables seamless integration with EHR systems, remote monitoring platforms, and third-party health data ecosystems
Aging medical device software creates compliance risk, integration bottlenecks, and security vulnerabilities. We modernize legacy codebases, migrate to cloud-native or hybrid architectures, re-engineer user interfaces for clinical usability, and bring older systems into alignment with current IEC 62304 and cybersecurity requirements. This is done without disrupting clinical operations.
Software lifecycle process requirements are followed from the first line of architecture planning through final software release.
For standalone health software and SaMD products, we follow the requirements for product safety and security that go beyond IEC 62304.
Electronic records and electronic signature requirements are addressed in software design, not added post-hoc.
Risk management activities are conducted at every stage of development, with documented risk control measures per hazard analysis.
Protected health information (PHI) handling is built into data architecture with access controls, audit logging, and encryption by default.
For products entering European markets, we align software documentation to EU Medical Device Regulation and In Vitro Diagnostic Regulation requirements.
Interoperability standards are supported natively in our integration architecture.
Talk to an expert medical device software developer about your device requirements, regulatory pathway, and development timeline.
Talk to Expert Medical Device software DevelopersAI is changing what medical devices can do. It is enabling devices to detect anomalies before a clinician notices them, generate diagnostic insights from imaging data in seconds, and adapt therapy delivery based on real-time patient response. We build these capabilities into medical device software with the engineering rigor that regulated development demands.
Our AI and ML integration work for medical devices includes:
→ Computer vision and image analysis for radiology, pathology, ophthalmology, and dermatology applications
→ Natural language processing (NLP) for clinical documentation and voice-enabled device interfaces
→ Predictive analytics for patient deterioration risk, equipment maintenance, and clinical outcome modeling
→ Real-time anomaly detection in physiological sensor data from wearables and implantables
→ Federated learning architectures for privacy-preserving AI model training across distributed clinical sites
We build remote patient monitoring platforms that collect, transmit, and analyze physiological data from wearable sensors, implantables, and home-based medical devices. Our patient monitoring system development work spans chronic disease management (cardiac, respiratory, diabetes), post-surgical monitoring, and ICU telemetry platforms.
We develop imaging software for radiology, pathology, ophthalmology, and dermatology that handles DICOM data processing, AI-assisted image analysis, and clinical reporting workflows. Our diagnostic imaging system development capabilities include PACS integration, 3D reconstruction, and DICOM-compliant viewer applications
We engineer the software that controls and monitors smart therapy devices: insulin delivery systems, smart inhalers, infusion pumps, neurostimulators, and implantable device management platforms. Our development includes real-time control logic, dose calculation algorithms, adverse event monitoring, and clinician-facing dashboards.
We build analytics layers that transform raw device data into clinical insights. This includes real-time dashboards for clinical teams, outcome analytics for hospital administrators, and regulatory-grade data exports for post-market surveillance and adverse event reporting.
We develop fleet management platforms for medical device manufacturers and hospital biomedical engineering teams. This includes device lifecycle tracking, over-the-air (OTA) firmware update management, cybersecurity monitoring, and maintenance scheduling tools.
We build the integration software that connects your medical devices to clinical information systems: EHR/EMR platforms, laboratory information systems (LIS), pharmacy management systems, and clinical trial data management platforms. All integrations are built to HL7 FHIR or HL7 v2 standards with full audit trail support.
The cost to develop medical device software typically ranges from $40,000 to $500,000+, depending on complexity, compliance needs, and features. Every project is unique — share your requirements to get an accurate estimate tailored to your device.
We protect your IP, patient data, and regulatory strategy through strict NDAs, transparent practices, and a clear decision trail throughout every stage of development.
Our structured delivery model keeps projects on budget without cutting corners on compliance documentation, validation, or security. Quality and regulatory integrity are never traded for cost.
Our team brings hands-on experience with IEC 62304, ISO 14971, FDA 510(k), EU MDR, HL7 FHIR, DICOM, and HIPAA compliance from day one of your engagement.
Every delivery goes through IEC 62304-aligned quality assurance including unit, integration, system, and software validation testing. All QA artifacts are documentation-ready for regulatory submission.
It's an AI-driven healthcare platform that automates patient engagement and consultation processes, helping healthcare providers deliver efficient, on-demand services while improving operations for urgent care.
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Carepoint is a solution dedicated to the pharmacy industry with a variety of tools needed to manage any pharmacy.
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Droice Labs is a middleware designed to transform messy, unstructured patient data into clean, analysis-ready formats for clinical trials.
Read Case Study →We start with your device requirements, intended use, user population, and regulatory pathway. This phase produces a Software Requirements Specification (SRS), risk pre-assessment, and software safety classification per IEC 62304. We align on architecture approach, compliance strategy, and project timeline before a single line of code is written.
Architecture design, system decomposition, UI/UX for clinical environments, and interface design for hardware integration. This phase produces a Software Design Document (SDD), architecture decision records, and a traceability matrix linking design to requirements. Risk controls from ISO 14971 are embedded into design decisions here.
Development follows IEC 62304-aligned change control with continuous integration, code review, and unit testing at every sprint. We maintain a real-time software development file throughout this phase, so documentation never falls behind the code. Cybersecurity controls are implemented per FDA pre-market cybersecurity guidance.
System integration testing, software validation, and release management. We deliver a complete release package including test reports, traceability matrix, software bill of materials (SBOM), and version history documentation. For products requiring regulatory submission, we package your software development file for FDA or CE marking review.
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We develop software for a wide range of medical devices including remote patient monitoring devices, diagnostic imaging systems (radiology, pathology, ophthalmology), infusion pumps, insulin delivery systems, smart inhalers, neurostimulators, clinical decision support tools, and connected hospital equipment. We work with both Software as a Medical Device (SaMD) products and software embedded in physical medical hardware (SiMD). Our experience spans FDA Class I, Class II, and Class III device categories.
Development timelines vary significantly by device complexity and regulatory requirements. A focused MVP for a Class I or Class II device with basic regulatory documentation typically takes 4 to 9 months. A fully-featured platform requiring extensive validation, AI model training, and regulatory documentation for FDA 510(k) or CE marking submission typically takes 12 to 24 months. We provide a detailed timeline estimate after reviewing your requirements, regulatory pathway, and intended use.
Yes. We build integrations between medical device software and EHR systems using HL7 FHIR R4, HL7 v2, SMART on FHIR, and direct API integrations with Epic, Cerner (Oracle Health), Meditech, and other major EHR platforms. Our healthcare API integration work includes real-time data exchange, bidirectional sync, and CDS Hooks for clinical decision support integration.
Software as a Medical Device (SaMD) is software intended to fulfill a medical purpose without being part of a physical medical device. Examples include AI diagnostic tools, clinical decision support algorithms, and standalone health monitoring apps. Software in a Medical Device (SiMD) refers to software that controls or runs on a physical device, such as the firmware in an infusion pump or the imaging software in a CT scanner. We develop both, with the compliance approach tailored to the regulatory classification of the software type.
Yes. IEC 62304 software lifecycle process requirements are followed across all our regulated medical device software projects. ISO 14971 risk management is conducted throughout development, with documented hazard analyses, risk controls, and residual risk evaluations. We produce all associated documentation artifacts as part of the project delivery, not as a separate engagement.
We start with a discovery phase to understand your device requirements, intended use, user population, and regulatory pathway. This informs the architecture, compliance strategy, and team composition. From there, we follow a structured IEC 62304-aligned development process with continuous documentation, regular client reviews, and milestone-based delivery. We act as your full development partner, not just an outsourced coding team.
Yes. We produce software documentation packages aligned to FDA 510(k), De Novo, and CE marking requirements. This includes Software Requirements Specifications, Software Design Documents, risk management files (ISO 14971), verification and validation protocols, traceability matrices, and software bills of materials. We work alongside your regulatory affairs team or can serve as your regulatory documentation partner if you do not have one in-house.
