Medical Device Software Development Company USA
Software Engineering That Survives Regulatory Scrutiny
Custom medical device software, embedded, standalone, or SaMD, built to IEC 62304 and FDA expectations from the first line of code.
17 +
Years of Service
150 +
Happy Clients
510 +
Successful Projects
2400 +
Successful Sprints
Introduction
Medical Device Software Development Services
Regulatory clearance risk starts long before a submission gets filed. It starts in how the software underneath a device gets built. Fortunesoft is a medical device software development company that builds embedded, standalone, and SaMD software engineered to IEC 62304, ISO 13485, and FDA regulatory requirements.
Development extends into connected device and cloud architecture and independent verification and validation, treated as part of one coordinated process rather than separate specialties brought in only when a gap surfaces late. The result is software your regulatory team can stand behind, built by a team that already thinks in terms of design controls and traceability.
Built to IEC 62304 From Day One
Development follows IEC 62304's lifecycle requirements from the first sprint, instead of retrofitting compliance once the software is mostly built.
Software That Coordinates With Your Hardware Timeline
Software development is scoped around your device's actual release schedule, not treated as a separate timeline that happens to run alongside it.
Full-Lifecycle Development, From Requirements to Release
Every stage, from requirements through release, is covered as one traceable record, not just the coding work in the middle.
Custom Medical Device Software Development
This is the core software engineering Fortunesoft delivers for medical devices: turning clinical and device requirements into software that can function safely and reliably as part of a regulated product. The engineering is shaped around the device's actual purpose, operating environment, and risk profile, rather than treating medical device software like a conventional application.
Embedded Software Development
Firmware and embedded systems get engineered for devices with real-time constraints and safety-critical requirements, where a race condition isn't just a bug.
Standalone Medical Device Software
When the software itself is the medical device, it gets built to its own regulatory classification from the start, not treated as an accessory to hardware that doesn't exist.
Software as a Medical Device (SaMD) Development
Software-only medical devices get purpose-built development from classification through release, since SaMD carries its own regulatory path distinct from embedded software.
Companion Mobile & Web Application Development
Patient- and clinician-facing apps get built to support a regulated device without compromising its classification, a different problem than building a typical consumer app.
Digital Therapeutics (DTx) Product Development
Software-delivered therapeutic interventions get built to the regulatory path they require, treated as a clinical product rather than a wellness app with clinical claims attached.
AI/ML Model Integration for Devices
Machine learning capabilities get incorporated while navigating the regulatory path they require, since AI/ML components raise questions regulators are actively refining guidance on.
User Requirements & Design Controls Definition
The requirements foundation your entire development record traces back to gets established first, since a weak requirements set undermines everything documented after it.
Software Configuration Management
Version control and change management get built for auditable, regulated environments, so every change traces back to a decision your quality system can defend.
Data Protection Implementation
We use encryption techniques, secure startup protocols, authentication systems, and device protection measures to safeguard patient information and maintain system reliability.
Not sure which development path fits your device?
Let Intelligence Work With You, Not Just For You
Agentic AI Engineering
Autonomous, multi-agent systems built to make decisions, collaborate, and execute complex tasks.
Vertical AI Consulting
Combining agentic intelligence with deep domain knowledge in EHRs, clinical ops, regulatory tech, and financial systems for maximum contextual precision.
LLM Toolchains & Production Systems
Integrating curated LLMs, secure RAG pipelines, and reusable components to accelerate delivery - without compromising on compliance or performance.
Our Agentic AI doesn’t just process—it perceives, learns, and acts. Build intelligence that understands your domain - and drives real action.
Compliance
Security, Compliance & Regulatory Alignment
IEC 62304 Lifecycle Compliance
Development follows IEC 62304's lifecycle requirements across every safety classification, from planning through maintenance.
ISO 13485-Aligned Development Process
Development plugs into a quality management process aligned to ISO 13485 requirements, not a parallel process your QMS has to reconcile.
ISO 14971 Risk Management
Risk analysis under ISO 14971 informs architecture decisions from the start, rather than getting documented after the fact to satisfy a checklist.
FDA Premarket Software Documentation Support
Documentation is built in the structure FDA premarket software submissions actually require, scoped to the US market rather than a generic international template.
Cybersecurity per FDA Guidance & AAMI TIR57
Cybersecurity risk gets managed using the same process structure ISO 14971 applies to safety risk, aligned with FDA guidance and AAMI TIR57.
SOUP/OTS Component Management
Third-party and off-the-shelf components get documented and risk-assessed per IEC 62304, rather than treated as a black box in the software record.
Legacy Software Compliance Assessment
Existing software gets assessed against current standards to identify the real compliance gap, not just the parts that are obviously missing.
Why Fortunesoft for Developing Medical Device Software?
Plenty of software teams can build software for a medical device. Fewer build it around real device risks, regulated development processes, and the FDA expectations that shape the software from requirements through release.
17+ Years of Healthcare & MedTech Expertise
With over 17 years of experience in healthcare and medical technology engineering, we understand regulated development, from device-specific requirements and clinical workflows to the documentation and traceability that need to hold up throughout the lifecycle.
Compliance-First Engineering
FDA expectations, IEC 62304, ISO 13485, and ISO 14971 get built into the development process from the start, rather than treated as compliance work that gets added before submission.
Deep IoT & Embedded Systems Expertise
Connected device ecosystems get engineered across firmware, embedded software, cloud services, mobile applications, and healthcare systems, so the pieces work as one system rather than separate technology layers.
Advanced Cybersecurity Implementation
Security gets engineered into the device and its supporting software through encryption, authentication, secure boot, access controls, and monitoring, rather than added as a final security review.
Agile Yet Documentation-Driven
Development moves iteratively while requirements, design decisions, verification, validation, and traceability stay documented throughout the lifecycle.
Long-Term Support & Validation
Support continues beyond the initial release, covering software updates, post-market changes, validation, and ongoing compliance needs as the device evolves.
Partner with experts who speak healthcare fluently.
Connected Device & Cloud Data Architecture
BLE & Wireless Connectivity Development
Reliable wireless pairing and data transfer get engineered for connected devices, where a dropped connection has real clinical consequences.
Device Pairing & Onboarding Workflows
First-connection experiences get designed to work smoothly for patients and clinicians alike, not just for an engineer testing in a lab.
Cloud Backend for Device Data Ingestion
Secure infrastructure gets built to receive and store device data at scale, engineered for the volume a real deployed fleet actually generates.
Clinical Data Integration for Connected Devices
Device data gets routed into the clinical systems that actually need it, instead of sitting in a separate database nobody on the care team checks.
OTA Firmware Update Management
Over-the-air updates get managed through a safe, auditable process, so a fleet of deployed devices can be updated without compromising their regulatory status.
Edge Computing for Real-Time Device Data
Time-sensitive data gets processed on-device before it ever reaches the cloud, since some decisions can't wait on a network round trip.
Our Medical Device Software Development Process
Discovery & Requirements Planning
Discovery establishes your device's safety classification and requirements foundation before any development work begins, so downstream decisions rest on a real record.
Development & Design Controls
Development proceeds under design controls from the start, with every decision traced back to a requirement rather than made and documented separately later.
Verification & Validation
Verification and validation run throughout development, not as a single phase saved for the end, producing evidence as the software is actually built.
Release & Post-Market Support
Release follows a compliant process, and post-market maintenance continues under that same process, so patches and updates never fall outside your quality system.
Medical Device Software Development
at a Glance
IEC 62304 Lifecycle Development
ISO 13485-Aligned Process
Embedded & SaMD Development
FDA Documentation Support
Risk Management (ISO 14971)
Connected Device & Cloud Architecture
Independent V&V Capability
Human Factors Testing
Legacy Compliance Remediation
Post-Market Support
Want the full technical rundown?
Verification &
Validation Services
Test Strategy & Planning
A test strategy gets defined against your device's risk classification before testing begins.
Automated Test Suite Development
Automated test suites get built to catch regressions early, not just once before a release.
Design Controls Verification
Verification confirms the software meets its own design specification, stage by stage.
Software Validation Under Design Controls
Validation confirms the software meets user needs and intended use in real conditions.
Human Factors & Usability Testing
Formative and summative testing follow IEC 62366 and FDA human factors guidance closely.
Independent V&V for Existing Software
Existing software gets independently verified and validated against defined requirements and intended use, giving your development team a separate assessment of software already built.
Traceability Matrix Development
A traceability matrix ties requirements, design, code, and test evidence into one record.
Verification Documentation for Submissions
Verification evidence gets packaged in the form a submission reviewer actually expects to see.
Talk to our experts to explore the best solution for your requirements.
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Testimonials
Hear from Those Who
Chose Us
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
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
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
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.
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
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.
The group was thoughtful, smart, agile, and met all of our requirements.
Sean Colandrea
Co-Founder, ClinicalC2, US
Case Studies from Inc. 5000, FORTUNE 500, NASDAQ listed companies to stealth startups
Awards & Recognition
Celebrated for Innovation. Trusted for Excellence
Over the years, Fortunesoft has been recognized for its commitment to innovation, quality, and customer success in the FinTech and Healthcare technology space.
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Frequently Asked
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Blogs
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