medical device software development
At Vervelo, we engineer secure, FDA-compliant, and real-time medical device software for startups and global OEMs. From embedded firmware to cloud-connected diagnostics platforms, we develop smarter healthcare solution.
Our Medical Device Software Capabilities
Vervelo creates software systems for medical devices with precision. We provide services across embedded platforms, clinical tools, regulatory systems, connectivity layers as well as patient interfaces. Every delivery follows a transparent path starting from design through to validation.
Embedded Software Development
Our team writes code that runs directly on physical device hardware. The execution environment demands strict predictability; therefore, we structure the firmware to follow deterministic behavior. This software operates within microprocessors alongside controller boards typically found inside healthcare instruments. To meet your diverse deployment needs, we support multiple instruction sets frequently used across hospital electronics. Before integration testing begins, each build is subjected to thorough manual inspection.
Imaging Algorithms with Signal Pipelines
These embedded systems often work with sensors that capture raw data. This leads to the next layer of capability. We create systems that process visual signals along with electrical signals collected from medical equipment. Our algorithms identify clinically meaningful patterns extracted from continuous streams containing complex data. The resulting software helps automate scan reviews, waveform segmentation followed by early-stage diagnostic insights.
Internet-Connected Medical Devices
Devices that process signals while interpreting them must also relay this information toward remote systems. Our engineers implement communication protocols that link hardware through hospital servers. Each device is designed to handle live transmissions with high reliability without packet loss. The software reads sensor values then initiates appropriate digital responses within real time constraints. Once processed, every signal is securely stored inside cloud platforms or within localized infrastructure. These platforms synchronize data across labs, field units as well as practitioner dashboards.
Safety-Compliant Engineering Process
Systems running across networks during real time operations must be governed through precise regulatory workflows. We maintain an engineering process shaped by documented clinical frameworks besides traceable audit paths. Every requirement travels through clearly defined stages beginning from design followed by development and ending at verification before final release. The source code is matched with checklists, test plans plus risk-control mappings placed at each checkpoint.
Remote Patient Software Interfaces
Systems working inside clinical facilities follow formal protocols; however, patients interact with software differently when located remotely. We build digital interfaces that connect patients through secure access points reaching caregivers. These portals support daily data entry, appointment scheduling together with remote instructions or result retrieval.
We ensure consistent user experience across phones followed by tablets and later desktops.
Who We Serve
We develop medical device software for healthcare sectors that demand reliability plus strong compliance with regulations. Our partnerships span device manufacturers, hospitals, digital health firms, diagnostics labs as well as regulatory consultants. Each collaboration emerges from detailed domain knowledge that supports technical invention aligned with clinical relevance.
Medical Device Manufacturers
We work with firms that create monitoring tools, surgical systems, wearable sensors, plus implantable devices. These products require control logic embedded at the system level, functional interfaces, data storage utilities then update tools. We write code that supports the complete hardware cycle from initial models to software validated after commercial release.
Digital Health Startups
We support new healthcare companies working on innovations in diagnostics, mobile therapeutics plus remote care platforms. They count on us to deliver fast software iterations, stable system foundations then assistance in meeting compliance. Each product we co-develop creates a functional link between clinical reasoning and secure data flows.
Hospitals and Clinical Institutions
We collaborate with hospital groups planning to digitize devices like surgical machines, patient monitors plus asset tracking tools. These initiatives demand software that follows hospital governance policies, fulfills performance expectations then integrates existing infrastructure. We construct modules that interface with EHR systems, PACS software, LIS data plus telemetry records.
Diagnostics and Imaging Providers
We assist laboratories and imaging centers in designing platforms for scan processing, pattern recognition plus result delivery. Such institutions need advanced computation, steady calibration workflows then mechanisms for secure reporting. We create systems that present medical data clearly to pathologists, technicians or supervising physicians.
Type of Medical Device Software
Medical technology companies build different categories of software, each serving a particular medical function. At Vervelo, we develop software that powers devices internally plus software that exists as standalone clinical tools. These categories include systems that reside inside hardware as well as applications that perform regulated health tasks without needing embedded hardware.
Software for medical devices
We engineer embedded software for both wearable as well as implantable instruments that require consistent performance and safety-critical functionality. Our work spans across regulated categories as defined under international medical classifications. The focus remains to enable controlled data acquisition, automated actuation, and compliance with electronic health regulations and many more.
We develop for devices categorized under Class II as well as Class III classifications.
Class II Devices: These include instruments where failure poses moderate harm to the user; such systems must balance performance with patient safety across connected scenarios.
Examples include:
- Ambulatory blood pressure monitors
- Wearable ECG recorders
- CT scanners
- And, Continuous glucose monitors
Class III Devices: These devices refer to systems where malfunction may result in life threatening consequences, so the embedded software must ensure absolute accuracy with continuous operational reliability.
Examples include:
- Neurostimulators for seizure regulation
- Deep-brain stimulation units for movement disorders
- Cardiac pacemakers
- Implantable cardioverter-defibrillators
Software as a Medical Device (SaMD)
SaMD solutions function without integration into specific hardware yet are regulated as medical devices. They assist in clinical decisions, automate calculations then sometimes suggest diagnoses based on patient input or external data. Our engineers build such systems to deliver safe, interpretable plus clinically verifiable outcomes. We also ensure the software architecture complies with regional frameworks and lifecycle documentation.
Examples include:
- AI-based dermatology apps for lesion assessment
- Mobile ECG analysis platforms using cloud processing
- Digital therapeutics for mental health coaching
- Ophthalmic screening software for diabetic retinopathy detection
- Clinical calculators for oncology dosage personalization
Modules For Medical Device Software That Are Most Requested
At Vervelo, we design medical software modules with clear focus on function, safety, plus compliance. Each module serves a distinct purpose, followed by the next to build a complete and reliable system.
Mobile app
This module lets patients to interact with medical devices through secure, intuitive mobile platforms. For example, users of glucose monitors can access real-time data then communicate with physicians instantly.
Platform for the cloud
A centralized platform like cloud stores the data processes it on cloud using secure cloud infrastructure. It enables remote access by providers, which promotes continuity of care across hospitals, clinics, or home environments. We make the Management of the linked devices possible by integrating the system on cloud platforms.
Sophisticated analytics
Your data is transformed into insights that guide the treatment of the patient. Like an insulin pump, for instance, can alert physicians if dosage trends signal early-stage metabolic shifts. The medical device software employs AI and ML to analyze data from linked devices, to forecast the progression of the condition.
IoT-driven tracking of medical devices
Medical devices are tracked to identify their locations, ensure proper device disinfection and sanitation, decrease device search time, and provide remote maintenance.
Real-time health monitoring
The medical device software gathers the data, saves it to evaluates patient health data (such as blood glucose levels and sleep patterns) in order to automate hospital procedures and encourage individuals to take charge of their own health.
Regulatory Compliance & Safety Frameworks
This module ensures that wearable devices, plus implanted devices, transmit live diagnostics across secure medical networks. A wearable ECG sensor may share cardiac rhythms with monitoring centers without requiring patient input.
Our Process of Medical Device Software Development
Vervelo follow a structured five-stage process that ensures precision, safety, plus compliance from planning to deployment. Each stage is focused on delivering software that meets medical standards, enhances user trust, and supports long-term scalability.
Requirements Discovery
- We begin by gathering detailed inputs from clinical, technical, plus regulatory stakeholders.
- We identify device specifications, risk factors, integration needs, along with intended use.
System Architecture & Design
- Based on requirements from level 1, we design the complete software ecosystem in line with IEC 62304 guidelines.
- Architecture is defined for embedded systems, cloud connectivity, user interfaces, along with communication protocols.
Development of software for Integration
- We build the core software in parallel modules using expected coding standards.
- Device firmware with user dashboards are developed in isolation then integrated securely.
Verification & Validation
- Software undergoes rigorous verification and validation using both manual as well as automated testing
- Vervelo test for functional performance, failure response, cybersecurity resilience, along with usability and more.
Regulatory Readiness along with Deployment
- The final stage includes preparing documentation of the developed Medical Device Software
- We at Vervelo support compliance for Medical device software development with FDA, CE, and MDR and many more through structured evidence submission along with traceability maps.
Why choose us
At Vervelo, we do not just build software. We create clinical technology that stands up to scrutiny from regulators, engineers as well as end-users. We begin with a strong foundation in medical compliance, so every project is engineered to align with domestic requirements alongside international directives. Our team brings deep domain expertise across software engineering, quality assurance, clinical workflows, privacy law in addition to usability testing. Here are our number in prospective:
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Healthcare and Enterprise Projects
We have built software for hospitals, diagnostic labs, and home care providers. Each product addresses a separate medical task with a clear digital workflow.
Global Clients
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We serve healthcare providers in different locations with varied operational needs. Technical preparation kicks off with each engagement, at the end software that is ready to use concludes it.
Client Satisfaction and Success
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Our clients return to extend features that support patient care and provider efficiency. They choose our method because we build what is needed with reliable code.
Hours Worked
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k+
We write patient modules, clinical forms, and task-based dashboards in every project. Each unit follows proper documentation with tracked version control.
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Frequently Asked Questions
Medical Device Software
What is Software as a Medical Device (SaMD)?
Software as a Medical Device (SaMD) is a classification for software intended to serve a medical purpose. It performs this function without being a component of a physical medical device. At Vervelo, we develop SaMD applications that operate independently on platforms such as smartphones, tablets, in addition to smartwatches. These applications are utilized for diagnostics. They also assist with treatment planning plus patient monitoring.
What classes of medical devices do you develop software for?
We possess expertise in developing software for a wide spectrum of medical device classifications. These include the following:
Class II Medical Devices: These are devices with a medium risk profile that require special controls to assure safety plus effectiveness. We develop software that has received clearance from the FDA for devices like wearable glucose monitors. This software assists with monitoring patients in real time.
Class III Medical Devices: These are devices classified as high risk, they are mostly used to sustain human life. Our software for these critical devices undergoes the most rigorous level of scrutiny. This ensures maximum reliability, safety, as well as complete compliance with FDA regulations.
How do you ensure regulatory compliance with software quality?
Regulatory compliance combined with software quality forms the foundation of our development process. We strictly adhere to a Secure Software Development Life Cycle (S-SDLC). We also design our software to be in accordance with key international standards. Our team provides comprehensive documentation for regulatory submissions, like the FDA 510(k) premarket notification.
Do you offer support for post-deployment compliance and surveillance?
Yes. We offer modules that track medical device activity after market entry. These tools collect usage patterns, detect irregularities, notify responsible teams, and maintain logs useful for audits. Post-market data also helps clients respond to regulatory observations or clinical validation studies.
What experience does Vervelo have with wearable and implantable devices?
Our portfolio includes software for wearable heart monitoring tools, implanted insulin dispensers, signal transmission devices, in addition to body surface patches. We ensure consistent data collection, effective device communication, privacy controls, plus proper compatibility with associated systems for the smart functioning of systems.
Does Vervelo build infrastructure for medical data processing on the cloud?
Yes. We establish secure computing environments suitable for medical data handling. These platforms are equipped with structured storage, policy-based encryption, real-time access logs, compliance documentation, together with location-based data residency rules. This setup assures privacy, continuity, and traceability across different countries.
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