Developing Scalable Software for Medical Devices

Delivering better outcomes and clinical efficiency relies on medical device software that is secure, compliant, and scalable. Fortunesoft, a leading medical device software development company, develops custom solutions that enable real-time monitoring, diagnostics, data exchange, and automation across complex healthcare ecosystems.

We build platforms that connect clinicians, labs, manufacturers, patients, and caregivers. From embedded firmware and cloud connectivity to device data processing and workflow automation, our solutions enhance interoperability, improve safety, and support faster clinical decision-making.

With deep expertise in MedTech and regulated healthcare technology, Fortunesoft delivers scalable solutions for SaMD, diagnostic and therapeutic devices, wearable biosensors, imaging systems, remote patient monitoring platforms, etc. By integrating AI/ML, IoMT connectivity, and compliance-ready architectures, we help accelerate approvals, reduce risk, and enhance product performance.

At Fortunesoft, we specialize in medical device software development services with expertise in delivering:

AI-Driven Innovation for Medical Excellence

Fortunesoft develops AI-powered medical device software delivering predictive insights, faster clinical decisions, and improved patient outcomes.

Compliance with Global Regulatory Standards

Our medical device software follows FDA, IEC, ISO, HIPAA, and GDPR, ensuring secure, compliant, and audit-ready solutions for healthcare.

Seamless System Integration for Interoperability

We integrate medical device software with EHR/EMR, PACS, LIS, and IoMT devices, enabling real-time data exchange and coordinated clinical workflows.

Why Fortunesoft for Medical Device Software Development

Choosing the right development partner is crucial. Here's why businesses trust Fortunesoft:
  • Expertise in MedTech Industry

    With 16+ years of experience, Fortunesoft delivers medical device software development that ensures safe, compliant, and high-performing solutions across medical device platforms.
  • Experience in Multi Device Ecosystems

    We develop software for connected medical devices and monitoring systems, ensuring reliable integration and consistent performance across clinical environments.
  • Expertise in AI and Advanced Technology

    Fortunesoft builds reliable medical device software that improves clinical workflows, enhances device functionality, and supports safe, high-quality patient care.
  • End-to-End Product Engineering

    We manage the full software lifecycle from design and development to testing, validation, deployment, and ongoing support for regulated medical devices.
  • Agile Development Approach

    Our agile methodology delivers high-quality, adaptable medical device software through rapid iterations, continuous testing, and close collaboration with clients.

Core Capabilities in Medical Device Software Development

  • Real-Time Data Processing
  • Medical Device Tracking
  • Scalable System Architecture
  • Workflow Automation
  • Interoperability with EHR/EMR
  • Device Connectivity & IoT
  • Remote Monitoring Support
  • Data Analytics & Reporting
  • AI & Predictive Insights
  • Embedded Software Architecture

Have anything interesting in your mind?Reach out to us.

Medical device software development company

Medical Device Software Development Services

Medical Device Software Development Consultation

We provide expert consultation for custom medical device software, guiding product strategy, regulatory planning, technology selection, and software architecture to ensure safe, compliant, and high-performing device solutions.

Custom Medical Device Software Development

As a trusted medical device software development company, we build tailored software for diverse device types and clinical workflows, optimizing performance, maintaining regulatory compliance, and integrating seamlessly across hospitals, labs, and remote care settings.

Medical Device Mobile & Web App Development

We develop responsive mobile and web applications for medical devices, enabling real-time monitoring, device control, secure data visualization, and communication, all while adhering to healthcare standards.

Software in a Medical Device (SiMD) Engineering

Fortunesoft engineers embedded device software with safe operation, accurate data processing, and reliable device-to-device or device-to-system connectivity in clinical and laboratory environments.

Medical Device Software Integrations

We integrate medical device software with EHR/EMR, PACS, LIS, and lab platforms to ensure seamless data flow, interoperability, streamlined workflows, and timely, accurate patient information for better clinical decisions.

Medical Imaging Software Development

Our medical device software development company solutions deliver advanced imaging software with visualization, analysis, and reporting tools, enhancing diagnostic precision, improving clinician efficiency, and integrating seamlessly across hospitals and labs.

Cloud-Based Medical Device Software Solutions

Our medical device software development services deliver cloud platforms for connected medical devices. These solutions enable real-time data access, remote monitoring, and seamless interoperability while ensuring compliance with global healthcare regulations.

Software as a Medical Device (SaMD) Development

We develop SaMD solutions with built-in compliance, AI-driven monitoring, and clinical decision support to deliver accurate insights, faster reporting, and improved patient outcomes across hospitals, laboratories, and connected care settings.

Med Device Inventory Management Software

We design inventory management solutions to track devices and consumables in real time, automate alerts, and improve resource availability, ensuring smooth operations and regulatory transparency in healthcare facilities.

Global presence

We have offices in San Francisco California, Nashville Tennessee, New York in the US, and Bangalore, Mumbai in India. We also service clients from Delhi NCR, Chennai, Toronto, Montreal, Canada, Dubai UAE, Saudi Arabia, France, Italy, Switzerland, London UK, Netherlands, Ireland, Germany, and other parts of Europe.

medical-device-software-development-services

Use Cases for Medical Device Software Development

  • Hospitals & Health Systems

    Fortunesoft develops integrated software that connects medical devices with hospital systems to streamline workflows, improve diagnostics, and enhance patient monitoring and care coordination.
  • Blood Banks

    Our software manages donor information, inventory, and testing devices to ensure safe collection, accurate processing, and traceable blood supply management.
  • Research and Medical Innovation Centers

    Fortunesoft develops secure platforms for device prototyping, clinical trials, and research analytics, accelerating innovation in regulatory-ready MedTech.
  • Clinical and Diagnostic Laboratories

    We create solutions that automate lab workflows, manage diagnostic data, and integrate instruments for faster analysis, reduce errors, and secure data sharing.
  • Retail and Hospital Pharmacies

    We develop connected systems that integrate device data for accurate dispensing, stock visibility, and secure tracking of prescriptions and medical supplies.
  • Medical Education Institutions

    Our platforms support simulation-based training, device learning, and data analytics, giving educators and students practical experience with real healthcare technologies.
  • Nursing Homes & Hospice Centers

    We deliver software that supports resident monitoring, medication tracking, and device connectivity to improve care coordination, safety, and communication.
  • Home & Remote Patient Care

    Our remote care solutions connect patients and clinicians through medical devices, enabling real-time monitoring, early alerts, and proactive, data-driven care.

Why Fortunesoft Excels in Product Engineering?

At Fortunesoft, we excel in product engineering by delivering high-quality solutions, driving innovation, and ensuring the seamless integration of healthcare technologies.

Product Engineering

Our expertise in healthcare product engineering ensures that your app is developed with a focus on reliability, performance, and compliance with healthcare standards.

Agile Development

We adopt agile methodologies to maintain flexibility and adaptability throughout the development process, allowing for rapid iterations and prompt adjustments based on client feedback.

DevOps Methodology

Integrating development and operations, we ensure smoother deployments, faster time-to-market, and consistent application performance.

Continuous Integration

Our continuous integration practices guarantee that code is regularly tested and integrated, reducing errors and ensuring a seamless development process.

Testimonials

What Clients Say About Us

Working with Fortunesoft on the development of our Iguana Fintech Solutions, Credit Lending Platform and Middleware Solution has been a truly positive experience. Fortunesoft team has shown a deep understanding of middleware architecture, excellent problem-solving skills, and strong expertise in API integration. Their collaborative approach and efficiency have contributed greatly to a smooth and productive development process.

Dr. Telma Ingles
CEO, Kwattel SA

When I have an idea that needs to be translated into a capability, I reach out to you Fortunesoft Team. Thanks for never letting us down. I’ll be glad to refer Fortunesoft team and speak of their skill set and commitment to the projects & timelines. I’ve engaged Fortunesoft team on multiple occasions over a period of 2+ years to build Commerce and payment capabilities on SaaS and OnPrem infrastructures.

Rajagopalan M
Head of Regional Solutions- Ecosystem Partnerships & Marketplaces DBS Bank, Singapore

Fortunesoft IT Innovations has been an outstanding business partner for our company. After a terrible experience using offshore developers, we took a chance on Fortunesoft IT Innovations and they have been excellent to work with. The team is relentless in following agile development processes. They took the time to learn our business and it shows in the quality of the work they do. Their team has a broad range of skillsets and were able to help us with every aspect of our start-up company.

Conner Humphrey
Co-Founder, SalesC2, US

Competence, Service and Support are excellent. Our design tool works great and now generates revenue. The team is with you from building the website to making sure it runs smoothly even after the project is complete. Looking forward to creating more online solutions for our customers with fortunesoft!

Jaysond Miclat
Business Development Director, CollegeWear Inc, California, US

The group was thoughtful, smart, agile, and met all of our requirements.

Sean Colandrea
Co-Founder, ClinicalC2, US

I really appreciate the team’s efforts. It has been a pleasure to see this project become a reality. My hope is that the website will then stand as a testament to all of the effort invested in it by so many people. Thank you again for all of your support and assistance.

Katinka Csizmadi
Communications Assistant Manager, Live Language – Glasgow, Scotland.

A pleasure to work with. The project was actually delivered ahead of schedule. Regular scrum calls were clear and efficient. On budget and ahead of schedule. We will definitely work with them again.

Robert Brown
CEO, Options Away LLC – Chicago, US.

Frequently Asked Questions

Have questions? We are here to help.

Medical device software development is the process of designing, developing, testing, and maintaining software that powers or supports medical devices, including SaMD, diagnostic tools, and wearable technologies.
No. Our medical device software development services allow testing and validation through simulators or virtual environments before integration with the actual device.
Software in a Medical Device (SiMD) operates inside a physical device, while Software as a Medical Device (SaMD) runs independently and performs medical functions without direct hardware integration.
Fortunesoft uses AI/ML, cloud computing, IoMT integration, embedded systems, and secure healthcare data frameworks, ensuring that every technology complies with global healthcare standards.
Our medical device software development process follows global standards like FDA 21 CFR, ISO 13485, IEC 62304, HIPAA, and GDPR. We provide documentation and validation at every stage to ensure full regulatory compliance.
Fortunesoft stands out as a trusted medical device software development company with 16+ years of experience delivering AI-enabled, compliant, and interoperable software for diverse healthcare systems and devices.
Yes. We build software that connects with wearables, sensors, and hospital systems such as EHR/EMR, PACS, and LIS to ensure seamless data flow and device interoperability.
Yes. Security and compliance are integrated into every phase. Our medical device software development services include encryption, secure data exchange, and HIPAA-compliant architecture.
Yes. We create AI-powered medical device software that enables predictive diagnostics, automated workflows, and smart clinical decision support for healthcare providers.
Yes. We upgrade legacy systems to modern, compliant, and high-performance software through optimization, cloud migration, and interoperability improvements.
Yes. Our medical device software development company builds mobile and desktop apps for real-time monitoring, remote access, and data-driven clinical insights.
Fortunesoft serves various locations across the US, including but not limited to:

· New York, New Jersey, Connecticut – NYC, Manhattan
· Baltimore, Philadelphia, Columbia – Washington DC, Virginia, Pennsylvania, Maryland, Richmond, Arlington, Pittsburgh, etc.
· Nashville, Tennessee – Memphis, Gallatin, Franklin
· San Francisco, Bay Area, San Jose – California, Oakland, Fremont, Sunnyvale, Mountain View, Palo Alto, Santa Clara, Cupertino, etc.
· Chicago, Aurora – Illinois
· Florida – Miami, Tampa, Jacksonville, Orlando
· Texas – Dallas, Houston, San Antonio, Austin, Fort Worth
· California – Los Angeles, San Diego, Long Beach
· Boston, Massachusetts – Cambridge, New Hampshire
· Georgia – Atlanta, Columbus
· Colorado, Kansas – Denver, Colorado Springs

We also serve other locations across the United States and Canada. Contact us to find out how we can assist you in your city!

Our Locations

Nashville, US

Fortunesoft IT Innovations, Inc.,

180 N Belvedere Dr, Suite 7C, Gallatin, Nashville, TN 37066, United States

+1-615-298-7395

Bangalore, India

Fortunesoft IT Innovations Pvt. Ltd.,

#19, KMJ Ascend, 17 C Main, 1st Cross Road, 5th Block Koramangala Bangalore, KA 560095, India

080-42005185

San Francisco, US

Fortunesoft IT Innovations, Inc.,

Downtown Sunnyvale 640 W. California Avenue, Suite 210, Sunnyvale San Francisco, CA 94086, United States

+1-615-298-7395

Singapore

Fortunesoft IT Innovations Pte. Ltd.,

30 Cecil Street, # 19-06, Prudential Tower Singapore 049712

+65-3158-1762

Nairobi, Kenya

Fortunesoft Africa Limited

Fortis Suites, Hospital Road, Upper Hill, Nairobi, Kenya

P.O BOX 18809, 00500-Enterprise Road

+254 117 325 335

Sydney, Australia

Fortunesoft IT Innovations

Australia Square Plaza, Level 4,5 & 12,

95 Pitt Street, NSW, Sydney, 2000

+61-2831-14561

Nashville, US

Fortunesoft IT Innovations, Inc.,

180 N Belvedere Dr, Suite 7C, Gallatin, Nashville, TN 37066, United States
+1-615-298-7395

San Francisco, US

Fortunesoft IT Innovations, Inc.,

Downtown Sunnyvale 640 W. California Avenue, Suite 210, Sunnyvale San Francisco, CA 94086, United States
+1-615-298-7395

Bangalore, India

Fortunesoft IT Innovations Pvt. Ltd.,

#19, KMJ Ascend, 17 C Main, 1st Cross Road, 5th Block Koramangala Bangalore, KA 560095, India
+91-9900002145

Singapore

Fortunesoft IT Innovations Pte. Ltd.,

30 Cecil Street, # 19-06, Prudential Tower Singapore 049712
+65-3158-1762

Nairobi, Kenya

Fortunesoft Africa Limited

Fortis Suites, Hospital Road, Upper Hill, Nairobi, Kenya

P.O BOX 18809, 00500-Enterprise Road

+254 117 325 335

Sydney, Australia

Fortunesoft IT Innovations

Australia Square Plaza, Level 4,5 & 12,
95 Pitt Street, NSW, Sydney, 2000
+61-2831-14561

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