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Cardiology Device Software Development Services

Companion Apps and SaMD

With 20 years of experience in medical software engineering, ScienceSoft helps OEMs launch reliable, compliant companion software and SaMD alongside their cardiology devices. Our architects design solutions that integrate with real-world hospital systems and scale with product demand, even in the face of evolving regulations or tight launch timelines.

Cardiology Device Software Development Services
Cardiology Device Software Development Services

Cardiology device software development services include the design, development, modernization, support, and evolution of software solutions that accompany medical devices used in cardiology. These services cover the development of clinical, operational, and research-focused software such as remote cardiac monitoring platforms, diagnostic applications (incl. SaMD), device fleet management systems, clinical trial portals, and direct-to-consumer mobile apps.

ScienceSoft as a Trusted Partner for Cardiology Medical Device Software Development

  • Since 2005 in medical software engineering with 150+ successful projects.
  • Since 2011 in IoT and since 2012 in cloud technologies.
  • Proficiency in achieving and maintaining compliance with the requirements of HIPAA/GDPR, IEC 62304, ISO 13485, 21 CFR Part 820, 21 CFR Part 11, and more.
  • An official partner of Microsoft and AWS.
  • 9 principal architects with 15–25+ years of experience each to balance the security, cost-efficiency, and longevity of IoMT architectures.

Cardiology Device-Connected Software We Develop

These systems are designed to monitor and manage wearable ECG devices prescribed to patients by their healthcare providers. They collect cardiac signals and securely transmit them back to clinicians. Heart monitoring device software then processes and analyzes incoming data to detect clinically relevant events like arrhythmias or irregular variability, and notifies care teams when follow-up is needed.

Cardiology diagnostic software

Clinicians use device-connected diagnostic platforms to analyze patient cardiac signals — for example, ECG recordings collected during in-clinic procedures or downloaded from portable monitors or event recorders. These solutions support signal visualization, automatic detection of rhythm abnormalities, annotation, and report generation. Some OEMs build workstation-based tools that allow technicians to upload, view, and process device data offline.

Cardiology data review and reporting software

Clinical and research teams use these web and desktop tools to upload device recordings, view multi-lead waveforms with filters and zoom, review algorithm-marked events, annotate segments, and generate structured reports. Specialized dashboards can display clinically relevant trends (e.g., event burden over time, heart rate variability patterns, signal quality) and enable secure export or transfer of reports and data to downstream systems.

OEMs often offer companion software platforms that enable providers’ technical teams to track the location and condition of devices deployed across their facilities. These platforms support device registration, location tracking (e.g., via RFID or BLE), real-time status monitoring, and maintenance logging. They often integrate with service ticketing or inventory systems and may include dashboards for viewing usage patterns, service history, or error events across departments or sites.

Direct-to-consumer apps

Direct-to-consumer companion apps are designed for individuals using cardiology devices outside of a clinical setting. These apps display personal metrics such as resting heart rate, irregular rhythm flags, and heart rate variability trends based on periodic recordings. Users can view data over time, receive reminders, and export records to share with their healthcare provider.

Clinical study data portals

Specialized portals can support clinical studies that use cardiology devices as a data source. Using these portals as a device-connected layer alongside eClinical tools (e.g., EDC/CTMS/eTMF), sites can securely upload and QC device data, track adherence, and manage queries. Investigators, monitors, and sponsor teams can access role-based dashboards and ready device data exports.

High-Level Architecture of a Remote Cardiac Monitoring Platform

Below is a high-level architecture diagram for a remote cardiac monitoring solution deployed entirely within a hospital’s infrastructure. This setup suits providers with strict privacy or data residency policies that prevent protected health information (PHI) from being processed outside their own IT environment. However, the same functional architecture can be implemented in cloud or private cloud modes. In each of our projects, ScienceSoft’s architects define the deployment model early to align integrations, PHI handling, and validation scope.

Architecture of a Remote Cardiac Monitoring Platform

In the reference architecture, medical devices (e.g., wearable ECG sensors) are used by patients outside the hospital to continuously collect cardiac signals. These devices connect to a dedicated gateway, which securely transmits the data to the hospital’s infrastructure, separated by a firewall.

Inside the protected environment, high-frequency signals pass through the streaming processor, which segments and normalizes incoming data and detects clinically significant anomalies (such as atrial fibrillation or abnormal rate variability). Both signal fragments and initial event markers are stored in the data lake, where they remain available for further analytics. In parallel, real-time status data such as connectivity and signal quality is routed through a telemetry broker and also stored in the data lake for long-term tracking.

The data lake feeds data into the data analytics layer, which runs device‑specific or clinical algorithms, generates insights, and supports dashboards for different user groups. Events, whether from immediate stream-level detection or retrospective analytics, are passed to the event processing and alerting module, which routes actionable information to the appropriate personnel.

The API and orchestration layer coordinates all platform modules, managing data and event flows, integrating with other hospital systems (e.g., EHR or cardiovascular information system), and enforcing access policies. It also serves as the connection point for the device metadata catalog, which maintains operational records for monitored devices. The orchestration layer also handles secure device onboarding (provisioning, pairing, and device identity), configuration and threshold updates, certificate/key rotation, and device lifecycle events such as replacement and decommissioning. For connected devices that support it, the same control plane can manage firmware update distribution and reporting of update status.

Medical and non-medical users can access the system via the clinician interface or the admin or technician interface, respectively.

The entire solution can be delivered as a containerized or virtualized package, allowing vendors to deploy the same setup across multiple customers and ensuring that all protected health information (PHI) is stored and processed within the provider-controlled environment.

Services We Offer

Cardiology software product consulting

We assess your device’s use cases, target environments, and compliance landscape to define the right scope and architecture for its companion software. Our team prepares a feature list, data flow models, and integration plan, selects the tech stack, and estimates development time and costs. You get a clear roadmap and risk-aware plan before any code is written.

Software development from scratch

We design, build, and test full-scale companion software for cardiology devices, including back-end systems, web or mobile interfaces, and integrations. Our teams cover everything from infrastructure setup and database design to device data processing, API development, and validation-ready documentation.

Low-code development

We use platforms like Microsoft Power Apps to quickly build non-regulated application modules that support cardiology product operations: internal service workflows, inventory tracking add-ons, or administrative dashboards. We handle UI design, logic configuration, system integration, and testing to ensure fast delivery without compromising security or interoperability.

Software product support and evolution

Our teams can maintain, modernize, or evolve your already deployed software solutions. This includes fixing issues, updating third-party components, improving performance, and keeping documentation aligned with regulatory standards. We can also add new features as your product evolves or new use cases emerge.

Looking to Build Companion Software for Your Cardiology Device?

Cooperate with our consultants and solution architects to co-define your product’s core features, select optimal technologies, and estimate the investment required for each development stage. Let’s shape your vision together.

How ScienceSoft Tackles the Challenges of Medical Device Software Engineering for Cardiology

Bloating scopes and late ROI

It’s common for clients to come into a project with a large wish list. Stakeholders often want to cover every use case upfront, from complex analytics to advanced alerting, integrations, and multiple user roles. If core features are not prioritized early, this scope overload can lead to a drawn-out timeline, unpredictable costs, and long delays before the first version delivers value.

Solution

Solution

We help our clients break large product visions into manageable, value-driven releases. During discovery, our consultants define a minimal feature set that solves a real user problem (e.g., surfacing technician-level alerts in an equipment fleet management interface) while postponing high-effort, lower-priority features for later iterations. Working with your team, our specialists identify which parts of the system are most resource-intensive or technically complex early on to avoid surprises during implementation. This results in a predictable cost curve and faster time-to-benefit, without losing sight of the bigger product roadmap.

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Integrating with diverse hospital ecosystems without delaying adoption

OEMs building platforms for cardiology devices often face the challenge of integrating their software into each hospital's unique IT environment. Without proper integration planning, this creates friction for provider customers who do not see how the OEM’s product can be smoothly and quickly onboarded alongside their existing tools.

Solution

Solution

During the discovery phase, ScienceSoft works closely with the OEM team to understand how their product is expected to fit into clinical and operational workflows. We identify which integrations will have the biggest impact on adoption — whether it’s connecting to EHR systems for clinical visibility or ITSM tools for service ticket routing. Based on these findings, we recommend a combination of public APIs, direct system integrations, and data standards like FHIR or HL7 to support fast, flexible connections. This approach helps your product integrate more easily across diverse environments and reduces onboarding friction for your provider clients.

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Scaling device onboarding and lifecycle management without support overload

Even when data processing architecture is strong, remote monitoring products often struggle at scale due to operational friction: device provisioning, patient pairing, replacements, connectivity troubleshooting, and version fragmentation across customers. As a result, OEM teams face rising support costs and inconsistent device behavior across sites.

Solution

Solution

In medical device tracking solutions, ScienceSoft’s architects design operational controls around secure device identity and lifecycle workflows. This includes provisioning and pairing flows, device metadata and ownership tracking, configuration and threshold management, and structured telemetry (connectivity, signal quality, battery, gateway status) to support proactive support and fleet health dashboards. Where the device ecosystem allows, ScienceSoft also implements firmware update orchestration and update status monitoring, with audit trails and validation-ready documentation aligned to regulated change control.

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Reducing alert fatigue while keeping sensitivity clinically acceptable

In cardiac monitoring, “more alerts” rarely means “more value.” If thresholds are not tuned to clinical reality, alerts become noisy, clinicians lose trust, and adoption drops, even when the underlying algorithms are strong. OEMs also need to prove how alerts are generated, routed, acknowledged, and improved over time without introducing uncontrolled changes.

Solution

Solution

ScienceSoft helps OEMs design alerting as an end‑to‑end workflow: multi‑tier severity levels, configurable rules per site or patient cohort, suppression and deduplication logic, and escalation paths mapped to real care team roles. The patient monitoring platform can also capture feedback loops (dismissals, reason codes, follow‑up outcomes) to continuously improve triage logic and support auditability. This approach increases signal‑to‑noise, improves clinician confidence, and makes future tuning and releases safer and more predictable.

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Managing compliance and change control throughout the project lifecycle

Software that accompanies cardiology devices often operates in a regulated context: it may fall within the SaMD scope or be tightly coupled to regulated hardware. Even minor changes to features or workflows can trigger revalidation, regulatory review, or stricter audit requirements if compliance isn’t built into the process.

Solution

Solution

ScienceSoft structures medical device software projects to support compliance at every stage. We apply documented controls for access management, data protection, auditability, and risk mitigation within the SDLC. Each feature or change request is assessed not only for business impact but also for its potential regulatory implications. When requirements evolve (as they often do), we document change sets and maintain updated traceability matrices and validation artifacts, so regulatory submissions or internal audits aren’t delayed by missing documentation. This gives our clients a clearer path to compliant releases, even as the product grows in complexity.

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Turning device data into evidence without breaking traceability and governance

Cardiology OEMs often need more than patient monitoring: they must validate algorithms, investigate edge cases, support clinical studies, and respond to post-market signals. Without a structured way to trace insights back to raw ECG segments, teams lose time, evidence becomes hard to defend, and changes to models or thresholds become risky.

Solution

Solution

ScienceSoft builds evidence-ready data workflows on top of the monitoring platform: annotation and review workbenches, traceability from flags to signal fragments, dataset governance (lineage, versioning, access control), and export pipelines for research and sponsor systems (e.g., CTMS or other trial software when relevant). The result is a platform that supports day-to-day monitoring and long-term evidence generation, while keeping audits, investigations, and regulated updates faster and more controlled.

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Making AI features useful without adding risk or cost overhead

OEMs increasingly want to add AI features to their platforms — to improve efficiency, reduce errors, or personalize user experience. But building large, opaque models that reason on clinical data introduces compliance, cost, and explainability concerns, especially in hospital environments.

Solution

Solution

ScienceSoft recommends a phased approach to AI adoption that starts with low-risk, infrastructure-light components. For example, in a clinical trial portal, we might implement a retrieval-based assistant that lets researchers find documentation or summarize past records via natural language, without letting the model generate anything new. In fleet management platforms, simple ML models can flag duplicate device records using structured, non-sensitive metadata. These kinds of AI features deliver measurable value while staying fully explainable, compliant, and cost-effective.

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Technologies We Use to Build Software to Accompany Medical Devices

Device connectivity

Wi-Fi

5G

Bluetooth

Bluetooth Low Energy

NFC

Zigbee

NB-IOT

LoRaWAN

Cloud services

Amazon Web Services

Microsoft Azure

Google Cloud Platform

Real-time data streaming

RabbitMQ

Apache Kafka Streams

Apache Storm

Apache Flink

Apache Spark Streaming

Amazon Kinesis Data Streams

Azure Event Hubs

Data lakes

HDFS

Azure Data Lake

Databases / data storages

SQL

Microsoft SQL Server

MySQL

Oracle

PostgreSQL

NoSQL

Cloud databases / data storages

AWS

Azure

Google Cloud Platform

Google Cloud SQL

Google Cloud Datastore

IoT data analytics

AWS

Azure

Others

Back-end programming languages

Front-end programming languages

Languages

JavaScript frameworks

Mobile

Containerization tools

Podman

Docker

LXC

Container Registry

OpenVZ

Orchestration

Orkes

Microsoft Autogen

LlamaIndex

Haystack

GitHub Actions

Jenkins

GitLab

Apache Airflow

Amazon SageMaker

Databricks MLflow

AWS Glue

Weights & Biases

TensorFlow Extended

Azure DevOps

NVIDIA TensorRT

ONNX Runtime

Docker

Kubernetes

nginx

HashiCorp Terraform

Ansible

Our Clients Say

During our cooperation, ScienceSoft proved to have vast expertise in Healthcare and Life Science industries <...>. They bring top quality talents and deep knowledge of IT technologies and approaches in accordance with ISO 13485 and IEC62304 standards. I would also like to point out that ScienceSoft's team demonstrated a great engineering culture, proactive approach in work, and the communication was easy and clear.

I was impressed with the excellent level of responsibility, communication skills, and mobile competencies of both <ScienceSoft’s> management team and developers. All the tasks were completed accurately, promptly, and efficiently.

We have been very pleased with ScienceSoft. Our project required a large amount of industry specific methodology and algorithms <…> which the team handled well. I am particularly impressed by the cooperative nature of ScienceSoft's team. They are reliable, thorough, smart, available, extremely good communicators and very friendly. We would recommend hiring ScienceSoft to anyone looking for a highly productive and solution-driven team.