Software as a Medical Device Development Services
SaMD Built to Survive Regulatory Scrutiny.
Fortunesoft builds SaMD products for medical device companies that require validated systems, regulatory-ready architecture, and engineering teams that understand the compliance stakes.
17 +
Years of Service
150 +
Happy Clients
510 +
Successful Projects
2400 +
Successful Sprints
Introduction
Enabling Safe and Scalable Software for Modern Medical Devices
Software as a Medical Device operates at the intersection of clinical evidence, engineering precision, and regulatory accountability. Fortunesoft delivers SaMD development services across the full product lifecycle, from initial classification and architecture design through validation, submission support, and post-market surveillance.
Our teams collaborate with medical device companies, digital health innovators, and healthcare organizations to develop software solutions designed for the diagnosis, treatment, prevention, and monitoring of medical conditions. Every engagement is structured around your regulatory pathway, clinical context, and commercial timeline.
Regulatory-Aligned SaMD Architecture
Device classification-informed system design covering intended use definition, software safety classification per IEC 62304, and architecture documentation aligned with FDA SaMD guidance, EU MDR Annex I, and applicable IMDRF frameworks.
Clinical Validation and Verification
End-to-end V&V execution, including software requirements traceability, hazard analysis, risk management per ISO 14971, and clinical evaluation support, structured to meet submission expectations and withstand regulatory review.
Post-Market Surveillance and Lifecycle Management
Continuous monitoring, anomaly reporting, and product change management processes that keep your SaMD compliant through updates, version releases, and evolving regulatory expectations without disrupting clinical operations.
Our Software as a Medical Device Development Capabilities
Fortunesoft builds Software as a Medical Device for organizations that cannot afford submission delays, compliance gaps, or architecture decisions that don't hold up under regulatory review.
Custom SaMD Architecture and System Design
At Fortunesoft, we design SaMD architectures around your device classification, intended use, and regulatory pathway, not a generic software template. Every structural decision is made with IEC 62304 alignment, design control traceability, and long-term clinical scalability in mind from the first engagement.
Regulatory Strategy and Submission Support
Fortunesoft delivers end-to-end regulatory strategy across FDA 510(k), De Novo, PMA, and EU MDR CE marking pathways. Our team structures technical documentation, clinical evaluation evidence, and submission packages to meet regulatory authority expectations and reduce back-and-forth review cycles.
Clinical Validation and V&V
We execute verification and validation protocols built around ISO 14971 risk management, hazard analysis, and usability testing - producing submission-ready evidence packages. Our team ensures every V&V activity is traceable, documented, and aligned with FDA and notified body review standards.
Cybersecurity for Medical Device Software
Fortunesoft embeds cybersecurity controls across every layer of your SaMD product, threat modeling, penetration testing, and access governance aligned with FDA medical device cybersecurity guidance. Our team ensures your software meets security expectations at submission and throughout its market lifecycle.
Post-Market Surveillance and Lifecycle Management
Our team builds and manages post-market surveillance systems that keep your SaMD compliant as it evolves, covering anomaly reporting, CAPA management, complaint handling, and software update validation. We structure these processes to meet MDR and FDA post-market obligations without disrupting clinical operations.
Quality Management System (QMS) Setup
Fortunesoft designs and implements QMS frameworks aligned with 21 CFR Part 820 and ISO 13485, covering document control, design history files, change control, and audit readiness. We build QMS infrastructure that supports your regulatory submissions and scales with your organization as your SaMD portfolio grows.
Built for clinical rigor and regulatory accountability - from architecture to approval.
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
Your Compliance Framework for SaMD Development
GxP & GAMP 5 - Software Validation Framework
We classify all life sciences software using GAMP 5 (Second Edition, 2022) category methodology - determining the appropriate validation rigor for each system component.
ISO 13485 & IEC 62304 - Medical Device Quality & Lifecycle
We operate an ISO 13485:2016-aligned quality management system for all medical device software development, covering design controls, risk management, and post-market surveillance.
21 CFR Part 11 / EMA Annex 11 -Electronic Records & Signatures
FortuneSoft manages Computer System Validation (CSV) for GxP integrations - IQ/OQ/PQ testing demonstrates that inter-system data transfers are accurate, complete, and attributable.
ICH E6 (GCP) / CDISC - Clinical Trial Data Standards
We build clinical data capture systems aligned with ICH E6(R3) GCP (finalised 2023), supporting decentralised trials and risk-based monitoring with electronic source data.
FDA & EMA
We design software to satisfy FDA (21 CFR Part 11, SaMD guidance) and EMA (Annex 11, CTIS) requirements simultaneously -one validated system, one technical file, supporting submissions on both sides of the Atlantic.
Why Fortunesoft for for SaMD Development
Fortunesoft brings nearly two decades of experience in healthcare and life sciences engineering to SaMD development.Our teams understand the clinical, technical, and regulatory variables that define whether a medical software product reaches market on schedule or stalls in review.
17+ Years in Health and Life Sciences Technology
Deep experience across digital health, clinical research, hospital IT, and regulated medical software environments, applied to SaMD products across diagnostic imaging, chronic disease management, surgical planning, and remote patient monitoring.
Compliance-First Development Practice
Regulatory requirements are embedded into architecture decisions, development workflows, and documentation practices from day one, not retrofitted at the validation stage. This approach reduces submission risk and rework cycles across product timelines.
Modern SaMD Technology Stack
Cloud-native architectures, AI/ML integration, API-based interoperability, and DevSecOps pipelines structured for regulated software environments, supporting high-performance SaMD products without sacrificing validation integrity or audit readiness.
Clinical and Regulatory Domain Expertise
In-house expertise spanning FDA regulatory strategy, notified body submissions, clinical evaluation methodology, and risk management, enabling technical and regulatory workstreams to move in parallel rather than sequentially.
Configurable for Therapeutic Area and Device Class
SaMD products differ significantly across oncology, cardiology, neurology, and mental health applications. Our development frameworks are built for configurability, accommodating protocol-specific workflows, device classification tiers, and clinical endpoint requirements.
Sustained Engagement Beyond Launch
Post-market surveillance support, regulatory change management, software updates, and lifecycle documentation - structured so your SaMD remains compliant as the product evolves and regulatory guidance develops.
Proven SaMD engineering expertise with regulatory depth built in.
Challenges We Solve in SaMD Development
Defining intended use and safety classification
Navigating FDA, EU MDR, and IMDRF requirements
Validating AI/ML capabilities for regulatory review
Managing design control docs across agile sprints
Integrating SaMD with EHRs and clinical systems
IEC 62304-compliant development in agile workflows
Post-market surveillance and anomaly management
Cybersecurity risk across connected SaMD products
Supporting De Novo and predicate-based pathways
Software versioning compliance through updates
Key Integrations Supporting SaMD Ecosystems
EHR and Clinical System Integration
Secure, standards-based connectivity with hospital and ambulatory EHR platforms using HL7 and FHIR protocols, enabling validated patient data exchange, clinical decision support delivery, and source data access within existing care workflows.
Medical Device and Wearable Connectivity
Integration with FDA-cleared hardware devices, diagnostic equipment, and remote monitoring platforms, enabling continuous data acquisition aligned with clinical endpoint requirements for connected and hybrid SaMD deployments.
Regulatory Submission and QMS Platforms
Structured data exchange with quality management systems, eTMF platforms, and regulatory submission tools - supporting documentation traceability, change control workflows, and audit-ready records across the SaMD development lifecycle.
Pharmacovigilance and Safety Reporting Systems
Automated adverse event reporting, safety signal detection, and post-market data flows connected to pharmacovigilance databases, meeting MDR and FDA post-market surveillance obligations for software-driven medical products.
SaMD Solutions for Clinical
and Healthcare Use Cases
AI-Assisted Diagnostic Imaging Software
Clinical Decision Support Systems
Remote Patient Monitoring Platforms
Chronic Disease Management Applications
Mental Health and Behavioral Health SaMD
Surgical Planning and Simulation Software
Patient-Facing SaMD and Digital Therapeutics
Oncology Risk Stratification Tools
Cardiology Monitoring and Alert Systems
From concept to clinical deployment - we cover the full SaMD lifecycle.
Our SaMD Development
and Validation Process
Intended Use and Classification Analysis
Defining intended use statements, device classification, and regulatory pathway selection across FDA, EU MDR, and applicable international frameworks, establishing the regulatory foundation before architecture or development begins.
SaMD Architecture and Risk-Based Design
System architecture designed around IEC 62304 software safety classification, ISO 14971 risk management inputs, and clinical workflow requirements, ensuring design controls are traceable from requirements through verification activities.
Regulatory and Quality Planning
Establishing quality management system alignment, design history file structure, validation planning, and regulatory submission documentation frameworks before development milestones begin.
UI/UX Design for Clinical Contexts
Interfaces developed for clinical users - physicians, nurses, diagnostic specialists- were designed around workflow integration, cognitive load, and device environment constraints specific to each SaMD use case.
Core Development and System Integration
IEC 62304-aligned development with unit, integration, and system testing, combined with validated integrations to EHR, device, laboratory, and clinical data platforms through standards-based APIs.
Verification, Validation, and Clinical Evaluation
We conduct verification and validation activities, risk assessments, usability evaluations, and clinical documentation processes to generate regulatory submission packages that meet FDA and notified body requirements.
Cybersecurity Assessment and Hardening
Threat modeling, penetration testing, and security control implementation aligned with FDA cybersecurity guidance for medical devices, protecting patient data and device integrity across the product lifecycle.
Regulatory Submission Support
Technical documentation preparation, 510(k), De Novo, or EU MDR submission support, and response management for regulatory authority queries across target market jurisdictions.
Post-Market Surveillance and Lifecycle Management
Structured post-market monitoring, complaint handling, CAPA management, and software update validation - maintaining regulatory compliance as the product evolves in clinical use.
A structured, compliance-embedded process built to keep your SaMD on time and submission-ready.
Outcomes That Speak Louder Than Promises
From Vision to Reality
Life Sciences
Transformed Biomedical Equipment Logistics
Barcode-based tracking with real-time delivery updates and intelligent route optimization...
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Transformed Cardiovascular Data Extraction in Real Time
RS232 protocol-based real-time data extraction with parsing, normalization, and error alerts...
Life Sciences
A Healthcare Scheduling Platform Simplified Vendor Task Coordination
Centralized scheduling with microservices and communication control...
Life Sciences
Enabled SaaS CRM for Med-Device Sales
Secure AWS infrastructure with WAF, IAM, GPS tracking, and task automation...
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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