Medical Device Software Development Services
With over 13 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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Reimagine what’s possible with our medical device software
The backbone element of modern healthcare, medical devices are instrumental in preventing, diagnosing, and treating illnesses and diseases in a safe and effective way. Our company enables medical devices to unlock real-time monitoring, data analytics, and workflow automation by developing custom software solutions designed to your specific use case and regulatory requirements.
Medical device software is no longer optional
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 that performs well across multiple operating systems, ensuring uninterrupted data flows under different conditions. Our software is developed in full adherence to applicable regulatory compliance requirements and data security standards, including HIPAA, GDPR, FDA, and others.
Medical device software maintenance and support
The medical device is only as reliable as the software that powers it. Our support team makes sure your device software remains reliable at all times by conducting 24/7 monitoring and issue resolution. We deploy software updates and introduce minor fixes to keep the performance and security up to the mark.
Medical device software integration
Our developers integrate your medical device software with target healthcare systems, including EHRs, RPM solutions, telemedicine platforms, and more, to deliver a nuanced view of a patient's condition and create a more informed healthcare environment for more accurate decision-making.
Medical device software development consulting
Our lead developers and software architects apply their hands-on knowledge, polished by 300 projects, to provide advice on the architecture of your device software, optimum technology stacks, necessary modules, and implementation roadmap.
Medical device software solutions we deliver
Embedded software for medical devices
Our team of experts develops real-time, compliant, and highly reliable software for diagnostics, therapy, and monitoring that seamlessly integrates with your device's hardware. We design your embedded software to handle accurate data processing and share real-time medical device data with other devices and computer systems.
Software as a medical device (SaMD)
We develop smart, standalone medical software designed to advance the diagnosis, management, and treatment of medical conditions and diseases. Paired with other medical devices or general-purpose hardware and software, our SaMD solutions empower data-driven decision-making with a richer data landscape.
Powering breakthroughs in all aspects of care
Medical devices have become the driving force behind the healthcare revolution, orchestrating innovations across every stage of care.
Remote patient monitoring and telemedicine
Our software helps medical devices collect and analyze patient vitals, including heart rate, blood pressure, glucose levels, and more, and then transmit this data to RPM systems and other healthcare platforms for further analysis.
Patient monitoring
Thanks to real-time data collection, advanced analysis, and automated reporting, our SaMD solutions let healthcare professionals adopt a proactive approach to patient monitoring and get a fuller picture of a patient’s health.
Diagnostics
Our developers integrate medical device software with AI algorithms to enhance the accuracy of in vitro diagnostic medical devices, imaging equipment, endoscopes, and other diagnostic tools, allowing them to identify the slightest abnormalities and potential issues.
Medication management
We develop medical device software that facilitates medication scheduling, delivery, and administration. Thanks to built-in AI algorithms, our medical device software can analyze patient data, allowing doctors to adjust drug dosages and delivery timings in real time.
Treatment delivery
By analyzing patient data and integrating it with EHR, our medical device software allows healthcare providers to create personalized treatment plans and optimize them based on individual patient needs and responses.
Rehabilitation and therapy
Our medical device software empowers both therapists and patients to advance rehabilitation and personalize therapy programs, providing care teams with essential metrics to track patient progress remotely and on-site.
Medical device software integrations we perform
Seamless communication between medical devices and software is the bedrock of data-driven healthcare. 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
Data interoperability between RPM devices and apps sets the stage for a more connected healthcare ecosystem, allowing for early disease detection, timely interventions, and improved communications between all parties involved in care.
Telehealth applications
Our team integrates your medical devices with telehealth apps, allowing real-time patient data to flow directly into virtual consultations. Relying on medical device input, healthcare professionals can provide more accurate diagnoses informed by a complete patient condition overview.
EMR/EHR systems
We enable automated data transfers between medical devices and EMR/EHR systems to eliminate manual data entry for healthcare staff, promote better care coordination within care teams, and give healthcare providers the tools to provide the right care, to the right patient, at the right time.
Chronic disease management apps
Combined with vital signs data from medical wearables, chronic disease management apps can flag potential complications or disease progression early on, allowing healthcare professionals to intervene early and adjust treatment plans.
Hospital management software
This integration transforms hospitals into efficient, data-driven, and patient-centered environments with optimized resource allocation, streamlined workflows, and a unified hub for medical device control.
Pharmacy management software
Seamless data exchange between medical devices and pharmacy software enhances medication accuracy and safety, allowing for automated medication dosing based on real-time patient vitals and easier tracking of medication delivery data from devices.
We kit out your medical device software with the latest technologies to give you smarter tools for faster diagnoses, more targeted therapies, and better patient outcomes.
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.
Quality assurance
Due to the high stakes involved, medical device software demands a rigorous QA process to ensure zero tolerance for errors. Our QA team is up to the task—we perform all types of testing to ensure the functionality, performance, and safety of your medical device software, documenting compliance with IEC 62304 and ISO 13485 requirements.
Lengthy certification process
Each year, regulatory bodies are bringing in more requirements, causing medical device innovation to die on the certification vine. Our company helps you get your medtech product greenlit faster by providing essential documentation, including life-cycle documentation, risk management files, and validation reports.
Drawn-out time to market
The medical device software approval process isn't quick — and software development shouldn’t become another timesink. We help you stay responsive to market demands by developing MVPs in 4 to 6 months and adhering to the pre-agreed timelines while keeping the quality of your software up to par.
Device integration and interoperability
The lack of standardized data formats and communication protocols hinders the effective use of medical device software by creating data silos and disrupting the flow of critical patient data. Our developers build your software in line with HL7, ICD-10, CPT, XDS/XDS-I, and other data standards, tapping open architecture design for easier integration and data sharing.
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 effective, combining user research, CVAA, and WCAG accessibility guidelines, and best industry practices.
Medical device software development process at Orangesoft
We're by your side throughout the entire journey, partnering on every aspect of full-cycle development.
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 13+ 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.
Our clients say it better
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 greatly based on its complexity, the software's safety class, necessary integrations, and the implementation 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 medical device has a physical component and might also include software, while SaMD is a standalone software that can act as a medical device.
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 to approving every medical device software. It means that the approval process varies depending on the potential risks your software poses to patients. Usually, your software goes through classification, premarket submission, and FDA review before it gets approved. If your software doesn’t get the approval, the FDA can suggest necessary changes.
- 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.