Custom Reliable Software Solutions for Modern Medical Devices
From wearable health monitors to advanced diagnostic systems, we specialize in building high-performance, regulation-ready software for medical devices. With deep expertise in healthcare and 8+ years of proven delivery, Celestial Infosoft helps medtech innovators bring compliant, scalable solutions to life faster and smarter.
8+
Years of Expertise
350+
Our Global Clients
180+
IT professionals
1000+
Completed Projects
\ Why we \
Trusted by startups and established medtech companies alike, Celestial Infosoft combines regulatory knowledge with modern tech expertise to deliver software that meets clinical standards and exceeds user expectations.
8+ Years in Healthcare IT with proven success in developing secure and reliable medical software.
Regulatory Expertise with FDA, HIPAA, MDR, and IEC 62304 compliance from the ground up.
Certified Development Team skilled in ISO 13485-aligned processes and risk-managed delivery.
Multi-Platform Solutions including embedded firmware, mobile health apps, and cloud platforms.
Agile & Scalable Models tailored to medtech startups and enterprise device manufacturers.
End-to-End Partnership from concept, prototyping, and validation to post-launch support.
\ Our offering \
We develop secure and compliant software for Class II and Class III medical devices, including:
Remote care devices (e.g., smart inhalers, insulin pens, ECG monitors).
Implanted or wearable diagnostics (e.g., neurostimulators, pacemakers).
Hospital-based systems for real-time monitoring and control.
These solutions enable continuous patient monitoring, early condition detection, and precision-based treatment delivery.
We specialize in building standalone software that meets regulatory definitions of a medical device. Platforms we build for:
Smartphones, tablets, and wearables
Desktops, web apps, and connected displays
Use cases include AI-assisted diagnosis, dose calculators, digital therapeutics, and personalized care assistants.
\ Who We Serve \
Hospitals and medical centers
Healthcare software providers
Healthtech startups
Home care providers
Mental health providers
Medical device manufacturers
Pharmaceutical companies
Health insurance companies
Healthcare NGOs and Non-Profits
Fitness & wellness companies
Laboratories and research centers
Medical biotech companies
\ Features \
We develop user-friendly mobile applications that provide patients and healthcare professionals with instant access to medical device data anytime, anywhere. These apps enable real-time monitoring, personalized alerts, and seamless communication, empowering better disease management and patient engagement on the go.
Our software harnesses the power of artificial intelligence and machine learning to analyze data collected from connected medical devices. This enables predictive insights such as early detection of health risks, trend forecasting, and personalized treatment recommendations, helping clinicians make informed decisions quickly and improving patient outcomes.
We build secure and compliant cloud platforms that aggregate data from multiple medical devices, providing centralized storage, processing, and analytics. This facilitates scalable data management, real-time synchronization, and remote access while ensuring data privacy and adherence to regulatory standards like HIPAA.
Our solutions include Internet of Medical Things (IoMT) capabilities that track the location, usage, and maintenance status of medical devices in real-time. This helps healthcare providers optimize device utilization, streamline inventory management, reduce downtime, and ensure timely servicing and sanitization.
We create intuitive dashboards that offer healthcare teams a comprehensive view of patient vitals, medication adherence, and treatment progress in real-time. These visual tools support proactive care, enabling timely interventions and enhancing clinical workflow efficiency.
Our medical device software ensures seamless and secure exchange of health data between devices, EHR systems, and other healthcare platforms. By leveraging standardized protocols like HL7 and FHIR, we enable interoperability that supports coordinated care, reduces data silos, and enhances the overall healthcare ecosystem’s efficiency and accuracy.
\ Our Work \
\ our process \
We start by deeply analyzing your device goals, regulatory classification, and target users. Our experts create a risk-aware plan aligned with FDA, HIPAA, and IEC 62304 guidelines.
We build scalable and modular software architectures to support easy device updates, integration, and long-term evolution.
Our human-centered design ensures intuitive interfaces across devices, helping both patients and clinicians use the software confidently, regardless of tech proficiency.
Whether you need native mobile apps, cloud dashboards, or embedded firmware, we deliver performant, interoperable software using Agile or hybrid models.
We apply Secure SDLC practices, automated test pipelines, code audits, and documentation for full traceability and certification-readiness.
We support 510(k), CE marking, and MDR compliance through structured documentation and validation reporting, accelerating your time-to-market.
We ensure seamless, secure communication between your device and cloud/server infrastructure, covering everything from Bluetooth pairing to real-time alerts.
Our post-launch services include performance monitoring, compliance updates, bug fixes, and new feature development as your product scales.
\ You're Just One call away \
Quick form to get started
We discuss goals & possibilities
Clear plan, no surprises
We work on your dream.
\ Few Words \
\ FAQs \
We embed compliance with FDA, MDR, HIPAA, and IEC 62304 standards throughout the development lifecycle. This includes rigorous documentation, risk management, and validation processes to meet all regulatory requirements and support smooth market approval.
Yes, our solutions are designed for seamless interoperability. We use standard healthcare protocols like HL7 and FHIR to integrate with EHRs, lab systems, and a wide range of medical devices, ensuring smooth data flow and unified patient care.
Data security is paramount. We implement robust encryption, access controls, and continuous security testing to protect sensitive health data. Our solutions comply with HIPAA, GDPR, and other relevant privacy regulations to safeguard patient information.
We adapt our approach based on project needs, ranging from traditional Waterfall for well-defined scopes to Agile and Scrum for iterative development. This flexibility allows us to deliver high-quality products efficiently while accommodating evolving requirements.
We are curious to discuss your dream web project!
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