Medical Device Software Development Services
With over 15 years in the healthcare domain, Orangesoft develops reliable, fully compliant SaMD solutions and embedded software for medical devices that help medtech companies deliver better patient care.
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Medical device software, as secure as it gets
As your tech partner, we deliver medical device software engineering that meets the highest quality standards and complies with ISO 13485, IEC 62304, and ISO 14971. Our medical device software developers have a proven track record of bringing regulated systems to market, including solutions compliant with HIPAA, FDA, and MDR requirements.
Medical device software development services we offer
Orangesoft takes the hard work out of developing, integrating, and maintaining custom medical device software — to help you bring exciting innovation to your users.
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Medical device software development
We develop secure medical device software with robust architecture, fully compliant with ISO 13485 and IEC 62304 for Class B and Class C devices. Every project includes thorough documentation and traceability, ensuring readiness for regulatory submission and real-world deployment from day one.
Medical device software maintenance and support
Our engineering team delivers SLA-backed L2/L3 support to keep your medical device software reliable and secure. Beyond incident management, we monitor usage data, gather user feedback, and recommend improvements aligned with your roadmap and regulatory requirements.
Medical device software integration
Equipped with hands-on knowledge of ICD-10, CPT, FHIR, and DICOM, our developers integrate your medical device software with target healthcare systems and third-party tools, including EHRs, RPM solutions, telemedicine platforms, and more.
Medical device software development consulting
Consult our lead developers and software architects to build your development roadmap, design medical device software, or select the optimal technology stack. We also advise on regulatory strategy, compliance planning, risk management, scalability, and AI/ML feasibility.
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Medical device software solutions we deliver
Embedded software for medical devices
Our team of experts designs and develops embedded software for moderate- and higher-risk medical devices, including diagnostic and imaging systems and wearable and monitoring solutions with companion web and mobile applications. Developed in accordance with IEC 62304, ISO 13485, and ISO 14971, our software is engineered with patient safety in mind, delivering reliable, standards-compliant solutions ready for clinical use.
Software as a medical device (SaMD)
We develop smart SaMD solutions designed to advance the diagnosis, management, and treatment of medical conditions and diseases. Our approach combines a structured software development life cycle, user-centered design, clinical validation, and robust security, supporting use cases such as remote care software, digital therapeutics, clinical research and trials, and clinical decision support systems.
Medical device software integrations for better, faster clinical insights
Our medical device software integration services bridge the gap, allowing your devices to effortlessly communicate vital patient data to target healthcare systems.
Remote patient monitoring apps and apps for medical staff
Our team enables device data to flow automatically into the RPM app, giving clinicians real-time patient insights and supporting early disease detection. We also design smart system workflows, including teleconsultation triggers, clinical alerts, and automated vital sign recording.
Telehealth applications
We pair your medical devices with telehealth apps, enabling clinicians to track patient health between visits and deliver more accurate diagnoses informed by a comprehensive view of the patient's condition. Every integration is HIPAA- and GDPR-compliant, with end-to-end encryption and secure APIs.
EMR/EHR systems
Armed with practical knowledge of HL7, FHIR, and DICOM, our developers set up channels for data exchange between medical devices and EMR/EHR systems. Whether it's IoT gateways, companion mobile apps, or BLE, we ensure connectivity is reliable and compliant.
Chronic disease management apps
Our developers build a bridge between wearables and chronic disease management apps, allowing medical professionals to intervene proactively and adjust treatment plans based on a more comprehensive view of the patient's health.
Hospital management software
Integrated with glucose sensors, heart rate monitors, and other medical devices, HMS systems consolidate vital signs, lab results, and device data into a single hub. Our developers help healthcare organizations implement these integrations with real-time data flows and automated anomaly alerts.
Pharmacy management software
We connect medical devices and pharmacy management systems for smart pharmacy, telepharmacy, and chronic disease management. Regardless of proprietary protocols, we seamlessly interface systems from different vendors in compliance with HIPAA, GDPR, and local pharmacy regulations.
We equip your medical device software with modern technologies to enable faster diagnoses, more targeted therapies, and improved patient outcomes.
Medical device software development process at Orangesoft
We're by your side throughout the entire journey, partnering on every aspect of full-cycle development.
We help you navigate the biggest challenges in MedTech development
Our commitment goes beyond coding expertise – we understand the unique hurdles of the medical device industry and provide you with the knowledge, skills, and tools to turn your vision into reality.
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Security and data privacy
When developing medical device software, we ensure implementation of encryption, two-factor authentication, data anonymization and pseudonymization, and other security and data privacy safeguards. We use SBOM generation tools to keep every software piece under control and address potential vulnerabilities by keeping the software up-to-date.
Device integration and interoperability
The lack of standardized data formats and communication protocols across integrated systems creates data silos and disrupts the flow of critical patient data. Our developers build medical software in line with HL7, ICD-10, CPT, XDS/XDS-I, and other data standards, using open architecture design to enable easier integration and data sharing.
Lengthy certification process
Each year, regulatory bodies introduce new requirements that can complicate and slow down medical device innovation. We help you get your medtech product approved faster by providing essential documentation, including lifecycle documentation, risk management files, and validation reports.
Usability and user experience
In medical device software, poor usability can lead to deadly errors and longer task times. We design your solutions to be user-friendly, accessible, and aligned with clinical workflows by combining user research, WCAG accessibility guidelines, and best industry practices.
Reliable tech development partner for a changing world
Leverage our years of expertise to seize the endless opportunities in medical device software development.
IoT and healthcare expertise
We have been delivering healthcare software for 15 years, combining our domain knowledge with proficiency in IoMT. Our understanding of the specific challenges and workflows of MedTech allows us to create software solutions that are not only technically sound but also valuable for users within the domain.
Rapid project delivery
Fast delivery isn’t about breakneck speed. It’s about combining efficient processes, collaborative environments, and iterative approaches to increase project velocity without compromising quality, as well as using battle-tested technologies and frameworks. That’s exactly what we do to facilitate faster market entry.
Knowledge of healthcare standards
Our knowledge of medical device regulation, including HIPAA, MDR/IVDR, FDA, and others, helps you successfully navigate the regulatory landscape and prepare for premarket software submission to regulatory agencies. We provide clear and comprehensive documentation, including software description, SRS, software architecture design, and other crucial information, to facilitate the approval process.
Rigorous quality assurance and testing
When it comes to security, we leave nothing to chance. Our QA team performs all types of tests, including functional and non-functional ones, to safeguard your software's data and functionality. We also help you address the risks early by developing a tailored mitigation strategy that minimizes the likelihood and impact of potential failures.
Questions you might have
Schedule a free consultationHow much does medical device app development cost?
The development cost of a medical device software project varies widely based on its complexity, the software's safety class, required integrations, and the use of advanced technologies. Contact our team to get a ballpark estimate for your project.
What's the difference between a medical device and SaMD?
A physical medical device has a physical component and may also include software, whereas Software as a Medical Device is standalone software that performs one or more medical functions and can act as a medical device on its own.
Do we need to have a real device for SaMD software development?
We can develop an advanced simulation environment that mimics the functionality and behavior of a real medical device.
What is the software development standard for medical devices?
The IEC 62304 standard outlines a structured framework for the development, implementation, testing, and maintenance of medical devices. Adherence to this standard is essential for medical device manufacturers to ensure the safety and effective usage of medical devices. Other guidelines include ISO 13485 (a standard for quality management systems in medical devices) and FDA.
How does the FDA approve medical device software?
The FDA applies a risk-based approach for medical device software, which means that an exact regulatory pathway depends on the potential risks the software may pose to patients. Typically, the process includes software classification, premarket submission (510(k), De Novo, or PM), and review.
- 1. Intro callDuring a 30-minute meeting, our domain expert dives into your business and describes the steps for future collaboration.
- 2. Free discovery workshopTogether with you, our technical team defines the user flow, feature list, and project risks.
- 3. Project planningWe provide the implementation plan, timelines and estimations for your project.