Medical Device Software Development Services for Device Manufacturers, HealthTech Startups, and Clinical Organizations
Arkenea is a medical device software development company with 15 years of exclusive healthcare focus. We build embedded software for medical devices, Software as a Medical Device (SaMD), companion mobile applications, cloud platforms for device data management, and clinical integration layers, all developed to FDA, IEC 62304, and HIPAA standards from architecture through regulatory submission.
SCHEDULE A CONSULTATIONWhat Is Medical Device Software Development
Medical device software development is the process of designing, building, testing, and maintaining software that operates within or alongside physical medical devices, or functions independently as a diagnostic, therapeutic, or monitoring tool classified as a medical device by the FDA.
Unlike general healthcare software, medical device software is subject to a distinct regulatory framework that governs its entire lifecycle. The FDA classifies medical devices into three classes (I, II, and III) based on the level of risk to the patient. IEC 62304 further classifies the software itself into safety classes A, B, and C based on the severity of harm that could result from a software failure. These classifications determine the rigor of the development process, the depth of documentation required, and the regulatory pathway to market.
The Quality System Regulation (21 CFR Part 820) requires that medical device software be developed under formal design controls, including documented requirements, design reviews, verification and validation, and a complete Design History File (DHF). This is fundamentally different from how most healthcare application software is built.
Software as a Medical Device
Standalone software that performs a medical function on general purpose hardware without being part of a physical device. Examples include diagnostic image analysis applications running on tablets, clinical decision support tools on hospital workstations, and therapeutic applications on smartphones. SaMD is classified independently by the FDA based on the significance of the information it provides and the seriousness of the healthcare situation it addresses.
Software in a Medical Device
Software that is embedded within physical device hardware to control, monitor, or enable the device's clinical function. Examples include firmware controlling an insulin pump's delivery algorithm, the operating software in a ventilator, or the signal processing code in a cardiac monitor. SiMD is regulated as part of the device it controls and inherits the device's FDA classification.
Our Medical Device Software Development Services
Every service we offer is grounded in 15 years of delivering healthcare technology exclusively. Our engineers understand the regulatory constraints, safety requirements, and clinical workflow integration challenges that medical device software demands.
Embedded Software for Medical Devices
We develop firmware, real-time operating system (RTOS) applications, hardware abstraction layers, device drivers, and embedded application software for FDA Class I, II, and III medical devices. Our embedded development follows IEC 62304 safety classification requirements and produces the documentation needed for regulatory submissions.
Software as a Medical Device (SaMD)
We build standalone software that performs medical functions on general purpose hardware, including diagnostic applications, clinical decision support tools, treatment planning platforms, and therapeutic software. Each SaMD product is developed with FDA classification and IEC 62304 safety class applied based on its intended use and risk profile.
Companion Mobile Applications
We build iOS and Android applications that pair with medical devices via Bluetooth Low Energy (BLE) or Wi-Fi for patient data display, device configuration, therapy delivery tracking, and clinician dashboards. Our mobile development covers both consumer facing patient apps and clinical facing provider interfaces.
Cloud Platforms for Medical Devices
We design and deploy HIPAA compliant cloud infrastructure for medical device data aggregation, remote monitoring dashboards, over the air (OTA) firmware updates, device fleet management, and population health analytics. We build on AWS, Azure, and GCP with Business Associate Agreement (BAA) configurations.
Medical Device Cybersecurity
We provide security architecture design, threat modeling, vulnerability assessments, penetration testing, Software Bill of Materials (SBOM) generation, and alignment with FDA premarket cybersecurity guidance and NIST frameworks. Medical device cybersecurity is addressed at the architecture level, not added as an afterthought before submission.
Verification and Validation (V&V)
We develop test plans, test protocols, automated testing frameworks, requirements traceability matrices, and complete V&V documentation for IEC 62304 compliance and FDA submissions. Our V&V process covers unit testing, integration testing, system testing, and software validation against intended use requirements.
Types of Medical Device Software We Develop
Each category below represents an area where we have production delivery experience. These are working systems built under regulatory constraints, not theoretical capabilities on a capabilities slide.
Remote Patient Monitoring (RPM) Device Software
Cellular and BLE connected device software for vital signs monitoring, automated data transmission, and clinical alert systems.
Wearable Medical Device Software
Firmware and companion apps for wearable health monitors including ECG, blood pressure, glucose, and activity tracking devices.
Diagnostic Imaging Device Software
Image acquisition, processing, analysis, and DICOM integration for ultrasound, X-ray, MRI, and CT imaging systems.
Surgical and Intraoperative Device Software
OR workflow management, digital preference cards, surgical navigation, and real-time intraoperative data capture software.
Drug Delivery Device Software
Insulin pump algorithms, infusion pump control systems, inhaler tracking software, and connected drug delivery device platforms.
Cardiac Monitoring Device Software
Continuous cardiac monitoring, arrhythmia detection, Holter monitor software, and implantable cardiac device data management.
Point of Care Testing (POCT) Software
Rapid diagnostic device software, test result management, quality control systems, and LIS/EHR integration for bedside testing devices.
Neuromodulation Device Software
Neurostimulator programming interfaces, therapy parameter management, patient controllers, and clinician dashboards for neuromodulation systems.
Respiratory Device Software
Ventilator control algorithms, CPAP/BiPAP management platforms, respiratory monitoring interfaces, and device configuration tools.
Blood Collection and Transfusion Software
Blood bank device interfaces, transfusion management systems, barcode verification software, and donor tracking platforms.
Digital Therapeutics (DTx) Software
Evidence-based therapeutic applications delivered through software for chronic disease management, behavioral health, and rehabilitation.
Laboratory and IVD Device Software
In vitro diagnostics instrument software, laboratory automation, sample management, and results analysis platforms.
Who We Build Medical Device Software For
The regulatory pathways, technical requirements, and business constraints differ substantially across the medical device market. We have production experience across these segments, which means we do not need to learn your domain at your expense.
Medical Device Manufacturers
Established device companies needing embedded software development, companion mobile applications, cloud device management platforms, or modernization of legacy device software. We support IEC 62304 compliance, V&V documentation, and Design History File compilation for regulatory submissions.
View related case studies →MedTech Startups and Founders
If you are a non-technical founder building a new medical device, you need a team that understands FDA classification strategy, MVP scoping for regulated products, technology selection, and the pathway from prototype to 510(k) or De Novo submission. We guide founders through these decisions, not just the code.
Discuss your device concept →Pharmaceutical Companies
Pharma organizations developing companion diagnostic devices, digital therapeutics, or connected drug delivery systems that require regulated software components. We have delivered production software for Fortune 500 pharmaceutical companies and scaled engagements from single to multi-country deployments.
View related case studies →Hospitals and Health Systems
Clinical organizations needing custom software for in-house medical equipment, device integration with existing EHR systems, or centralized dashboards for medical device fleet management and biomedical engineering teams.
View related case studies →Laboratories and Research Organizations
Custom software for laboratory instruments, automated data collection systems, imaging analysis tools, and research devices requiring regulatory compliance for clinical use or commercialization.
Discuss your project →Consumer Health Entering Regulated Territory
Companies with consumer health products crossing into regulated territory who need FDA compliant software to support clinical claims or medical device classification. We help navigate the transition from consumer wellness to regulated medical device.
Discuss your regulatory pathway →Built for Regulatory Compliance from Architecture to Submission
Medical device software development operates under a regulatory framework that is fundamentally different from general healthcare software. IEC 62304 classifies medical device software into three safety classes: Class A where no injury is possible if the software fails, Class B where non-serious injury is possible, and Class C where serious injury or death is possible. The safety class determines the rigor of the development process, the depth of documentation required, and the testing protocols that must be followed.
FDA device classification (Class I, II, III) determines the regulatory pathway. Most medical device software products require either a 510(k) premarket notification or a De Novo classification request. Class III devices require Premarket Approval (PMA). Each pathway has distinct documentation, testing, and submission requirements that must be planned from the start, not addressed after development is complete.
We embed these requirements into the software architecture from day one. That means design controls per 21 CFR Part 820, risk management per ISO 14971, usability engineering per IEC 62366, and cybersecurity documentation aligned with FDA premarket guidance are part of the development process, not a compliance checklist applied before submission. This approach produces a Design History File that reflects how the software was actually built, not a retroactive documentation effort.
Our cybersecurity practice addresses the FDA's increasing focus on medical device security, including Software Bill of Materials (SBOM) requirements, threat modeling, vulnerability assessment, and alignment with NIST frameworks and FDA premarket cybersecurity guidance.
Medical Device Integrations and Connectivity
Medical device software rarely exists in isolation. It needs to communicate with clinical systems, other devices, cloud infrastructure, and patient-facing applications. Our integration team has 15 years of experience building these connections across the healthcare ecosystem.
- EHR integration via FHIR R4, SMART on FHIR, and HL7 v2.x for sending device data directly into Epic, Oracle Health, Athena, and eClinicalWorks
- Bluetooth Low Energy (BLE) connectivity for companion mobile applications pairing with wearable and portable medical devices
- Wi-Fi and cellular (LTE/5G) connectivity for continuous or periodic device data transmission to cloud platforms
- IoT device management for OTA firmware updates, fleet monitoring, remote diagnostics, and configuration management
- Medical data protocols including DICOM for imaging, IEEE 11073 for personal health devices, and FHIR Device resources
- Integration engine connectivity through Redox Engine and 1upHealth for multi-system healthcare data exchange
Our Medical Device Software Development Process
Medical device software requires a development process that satisfies both engineering quality and regulatory rigor. Each phase below is specific to medical device development, informed by what we have learned delivering regulated products over 15 years.
Regulatory Strategy and Classification
Before any development begins, we determine the FDA device classification (Class I, II, or III), the IEC 62304 software safety class (A, B, or C), and the regulatory pathway (510(k), De Novo, or PMA). This decision shapes every downstream development and documentation requirement. Getting it wrong here is the most expensive mistake in medical device software.
Requirements and Risk Analysis
We define software requirements, system requirements, and user needs documentation. Risk analysis is conducted per ISO 14971, establishing the risk management file that will be maintained throughout the product lifecycle. Requirements traceability is established from this phase forward.
Architecture and Design Controls
Software architecture, interface design, database design, and security architecture are documented as design outputs per 21 CFR Part 820 design controls. Design reviews are conducted at defined checkpoints. Architecture decisions are traced back to requirements and forward to verification activities.
UI/UX with Human Factors Engineering
User interface design follows IEC 62366 usability engineering principles. For safety-critical interfaces, formative and summative human factors evaluations are conducted to validate that the interface supports safe and effective use by the intended user population in the intended use environment.
Agile Development with Design Controls
Software development proceeds in iterative sprints with continuous integration, code reviews, and static analysis. Design control documentation is maintained alongside code, not produced retroactively. Each sprint produces working software and corresponding design history artifacts.
Verification and Validation (V&V)
Unit testing, integration testing, system testing, and software validation against intended use requirements. Automated testing frameworks are used where applicable to enable regression testing across releases. V&V documentation is produced for the Design History File.
Regulatory Submission Support
Design History File (DHF) compilation, 510(k) or De Novo submission documentation, cybersecurity documentation, SBOM generation, and risk management file finalization. We produce the technical documentation needed for your regulatory submission, not just the software.
Post-Market Support and Maintenance
Ongoing software maintenance, security patches, regulatory updates, complaint handling support, CAPA (Corrective and Preventive Action) integration, and post-market surveillance data management. Medical device software is not a build-and-forget product. We provide long-term support as your technical partner.
Medical Software We Have Built
Every project below was delivered by Arkenea from initial concept through production deployment. These represent working healthcare products with measurable business outcomes, not theoretical capabilities.
ORLink
Surgical Workflow and Device Management
We designed and developed a surgical workflow platform with digital preference cards, real-time intraoperative data capture from surgical equipment, and AI-powered scheduling algorithms. Built as an iPad application for OR teams with device connectivity and clinical data integration.
MiPHR
Connected Wearable Health Management
We developed a mobile health application with real-time integration with wearable medical devices for blood glucose monitoring, blood pressure tracking, and activity sensing. The application connects to patient wearables via BLE and transmits data to care teams through a secure cloud layer.
NPHub
Healthcare Workforce Platform
We designed and developed a full healthcare staffing platform from the ground up with applicant tracking, credential verification, and algorithmic job matching. Built as a multi-tenant SaaS product demonstrating our ability to deliver scalable, production-grade healthcare software.
Hamilton Physical Therapy
Clinical Device and EHR Integration
We built a custom EHR for physical therapy with clinical device integration, therapy progress tracking, customizable documentation templates, billing system connectivity, and secure messaging, all within a HIPAA compliant architecture designed for specialty clinical workflows.
HomeCareIQ
Connected Care Operations Platform
We developed a clinical operations platform for home healthcare with automated workflows, real-time patient data access from connected devices, staff coordination tools, and HIPAA compliant data storage for device-generated health information.
Novo Nordisk
Fortune 500 Pharmaceutical Device Software
We developed custom software solutions for Novo Nordisk, a global pharmaceutical company with connected drug delivery devices. What began as an app development engagement for one country operation scaled to four country deployments, demonstrating our ability to deliver enterprise-grade regulated software.
Our Medical Device Technology Stack
We select technologies based on the device's requirements, safety classification, and deployment environment. Every tool in our stack has been validated in production medical device applications where reliability and regulatory compliance are non-negotiable.
Embedded and Firmware
Mobile (Companion Apps)
Backend and Cloud
Database
Protocols and Integrations
AI and Analytics
Why Healthcare Organizations Choose Arkenea for Medical Device Software Development
Most software development companies that list medical device software as a service also build logistics platforms, e-commerce sites, and banking applications. The problem is that medical device software operates under regulatory constraints that are fundamentally different from other industries. When a firm splits its attention across verticals, the domain knowledge that matters most in regulated development is diluted.
Arkenea has worked exclusively in healthcare since 2011. Every engineer, designer, and project manager on our team works within healthcare every day. When you describe a 510(k) pathway or ask about IEC 62304 Class C documentation requirements, we already have the context that a generalist firm would need months to acquire. That accumulated knowledge translates directly to faster development timelines, fewer regulatory surprises, and software that passes review because it was built correctly rather than patched to comply.
We also bridge a gap that most competitors do not cover: the full stack from embedded device firmware through the companion mobile application through the cloud data platform through the clinical EHR integration. Most firms specialize in one layer. We build the entire system, which means fewer integration points between vendors and a single team accountable for the complete product.
- 15 years of exclusive healthcare software development, no other industries
- Full-stack medical device capability: embedded firmware through cloud platform through EHR integration
- Honest scoping and MVP guidance that prevents scope bloat in regulated product development
- Paid discovery phase producing functional specifications before development commitments
- Proven outcomes: client products that raised venture capital and generated multi-million dollar revenue
What Our Clients Say
Our 4.9 Clutch rating with a 5.0 average referral score reflects how clients experience working with Arkenea. These are healthcare organizations and founders who have been through the full development lifecycle with us.
"Arkenea understood the regulatory landscape from the first call. We did not need to explain what IEC 62304 required or how FDA classification affects development scope. That level of domain knowledge saved us months of back and forth compared to the generalist firms we previously evaluated."
"As a first time MedTech founder, I needed a team that could tell me what I did not know about bringing a regulated product to market. Arkenea helped me cut my initial scope in half and launch a compliant MVP that my first hospital customers actually adopted."
"The integration work was exceptional. Connecting our device platform to multiple EHR systems through FHIR while maintaining HIPAA compliance is technically challenging. Arkenea handled it with a level of healthcare integration expertise we had not found elsewhere."
Frequently Asked Questions About Medical Device Software Development
These are the questions that medical device companies, MedTech founders, and clinical organizations most commonly ask when evaluating medical device software development partners.
Start Building Your Medical Device Software
Whether you are a medical device manufacturer needing embedded software, a MedTech founder with a regulated product idea, or a clinical organization looking to build custom device management tools, we would like to hear about your project. No commitment required for an initial conversation.
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