Medical Device Software Development (SaMD/MDSW)
End-to-End Medical Device Software Development | From Concept to Certification
QMLogic is your trusted partner for Medical Device Software (MDSW/SaMD) development. We provide complete technical, regulatory, and project management support, ensuring your medical device software is safe, effective, and compliant with international standards and regulations such as IEC 62304, ISO 13485, ISO 14971, FDA 21 CFR, and EU MDR.
From concept and design, verification and validation to regulatory submission, and post-market surveillance, we guide medical device companies through the entire software development lifecycle. Our solutions are always audit-ready, compliant, and seamlessly integrated into your Quality Management System (QMS).
Medical Device Software Development Services
Custom Development
We are developers by DNA. Our team builds daily sophisticated software using cutting-edge technologies like React.js, Next.js, Spring Boot, and .NET. Development is not something we outsource; it's our core expertise, seamlessly integrated with our regulatory knowledge to create compliant, innovative solutions from day one.
- Compliance built into every line of code
- Developers and regulatory experts in one team
- IEC 62304 compliant by design
- Integrated with ISO 14971 Risk Management
- Designed with Cybersecurity per IEC 81001-5-1
- React, Spring Boot, .NET mastery
- Modern stack, medical-grade security
Verification and Validation
Rigorous testing isn't just a checkbox for us; it's engineered into every line of code. We utilize modern automated testing frameworks for unit, integration, and end-to-end validation, ensuring IEC 62304 compliance while delivering traceable reports that are ready for technical documentation.
- Compliant unit, integration, end-to-end testing
- Full-scale traceability for your technical documentation
- Automated test reports generation
- IEC 62304, IEC 82304, ISO 14981and ISO 62366 compliant
Quality Assurance & CI/CD
We integrate Quality Assurance (QA) and Continuous Integration/Continuous Delivery (CI/CD) practices directly into your medical device software development lifecycle, ensuring every release is safe, verified, traceable, and compliant. By combining automated testing, risk-based validation, and regulatory alignment, we help you deliver updates faster; without compromising compliance or patient safety.
- Automated testing & validation aligned with ISO 13485, IEC 62304 & EU MDR
- CI/CD directly linked with verification processes
- Risk-based QA strategies for patient safety & reliability
- Automated reports ready for documentation
- Continuous delivery pipelines tailored for regulated software environments
- Comprehensive testing coverage with traceability to design inputs & risk controls
Technical Documentation
We prepare audit-ready technical documentation to support FDA submissions, EU MDR conformity, and international approvals. We have experience creating compliant documentation packages including risk management files, usability engineering files, and design controls that satisfy IEC 62304, ISO 14971, and regulatory requirements. Our systematic approach ensures every requirement traces seamlessly from concept to verification, making audits stress-free.
- Software Requirements Specifications (SRS)
- Risk Management Files (ISO 14971)
- Verification & Validation (V&V) reports
- Design documentation & user manuals
- Complete traceability across all design controls
- Usability documentation (IEC 62366)
- Ready-to-submit documentation from day one
Project Management
Effective project management is critical for delivering medical device software that meets regulatory requirements and market expectations. QMLogic provides comprehensive oversight, ensuring that every phase is coordinated, traceable, and audit ready. Our medical device project management services cover:
- IEC 62304-compliant lifecycle management
- Anticipate pitfalls unique to medical devices.
- Regulatory submission readiness for FDA and EU MDR
- Cross-functional team coordination for development, QA, and regulatory alignment
- Align risk managers, clinical evaluation or cybersecurity department
- Agile project frameworks adapted for regulated environments
- We understand the full scope of Medical Device development projects
QMS Integration
Having built multiple quality management systems from the ground up, we speak your QMS language fluently. We quickly orient within any organization's processes, identify the right templates and procedures, and immediately begin working compliant to your internal standards. No learning curve, no compliance gaps, just seamless integration into your existing quality framework.
We combine deep business understanding with technical expertise, aligning software architecture with real-world QMS needs and regulatory expectations.
- Quick adaptation to client processes.
- Process-respectful implementation
- Seamless alignment with internal design controls.
- Business-driven development with focus on operational value
- Smooth system connectivity with existing QMS and data sources
- Validated, scalable architecture
“We don’t build software in isolation — we build it into your quality system, ensuring every line of code supports compliance, efficiency, and business continuity.”
Regulatory Affairs Expertise
Regulatory compliance runs through our veins; it's not an add-on service but integral to how we think and build. Whether targeting EU MDR, FDA, or MDSAP markets, we ensure your software meets all regulatory requirements from concept through post-market surveillance. With us, you get a complete package: innovative development paired with bulletproof regulatory strategy.
- EU MDR, FDA, and MDSAP compliance in every decision
- Experts in complex software classifications
- Strategy tailored for regulatory success
- Compliance connected directly to development
- Regulatory insight in every project phase
- AI/ML regulatory strategies
- Multiple successful regulatory submissions
Regulatory Affairs Expertise in Medical Device Software Development
Our regulatory affairs expertise ensures that your software is audit-ready, validated, and compliant with key standards, including:
- IEC 62304 – Software Lifecycle ComplianceDefines the required development and maintenance processes for SaMD/MDSW, ensuring safety, traceability, and regulatory approval.
- ISO 13485 – QMS for Medical SoftwareProvides the quality management framework to align software development with global medical device standards.
- ISO 14971 – Risk Management IntegrationEnsures risk identification, evaluation, and control are embedded into the software lifecycle, protecting patients and users.
- ISO 80002-2 – Computer Systems ValidationGuides computer system and software validation, ensuring reliable performance and regulatory acceptance.
- EU MDR 2017/745 – European medical device regulationSets the requirements for CE marking of medical device software, covering safety, performance, and post-market surveillance.
- FDA 21 CFR Part 11 & 820 - U.S. CompliancePart 11 governs electronic records and signatures, while Part 820 ensures quality system compliance for FDA-regulated software.
- FDA 510(k) – Market Access ClearanceDemonstrates substantial equivalence of your medical device software, enabling U.S. market entry.
- ISO/IEC 27001 - Information SecurityProvides a globally recognized framework for managing information security, ensuring medical device software protects sensitive health data.
- IEC 81001-5-1 – Health Software CybersecuritySpecifically addresses cybersecurity for health software, focusing on secure design, development, and maintenance of medical device software.
By combining technical expertise with regulatory mastery, we help MedTech companies:
- Design, build, and validate SaMD with regulatory compliance built in
- Develop audit-ready technical documentation from the start
- Accelerate EU MDR certification & FDA clearance
- Launch faster with a scalable, compliant, and future-proof software solution
Our unique approach ensures that every line of code supports not just your business goals, but also the regulatory framework that governs your market success. From concept to certification, we help you design, build, validate, and document your SaMD for a faster, smoother market launch.
Why QMLogic for Medical Device Software Development?
1. Regulatory Expertise Across Global Markets
Extensive knowledge of IEC 62304, ISO 13485, ISO 14971, EU MDR, and FDA 21 CFR 820 ensures your software meets all necessary regulatory and compliance requirements worldwide
2. Proven Track Record of Success
We have delivered multiple successful and fully compliant SaMD development projects, from initial concept to post-market surveillance, for startups and established MedTech companies alike.
3. End-to-End Project Management Integration
Our dedicated project management services ensure efficient coordination, transparent communication, milestone tracking, and proactive risk management across the entire development lifecycle.
4. Quality Assurance and Risk Management
Every phase of development is tightly aligned with ISO 14971 risk management and IEC 81001-5-1 cybersecurity standards, ensuring patient safety and data protection from the ground up.
5. QMS Integration & Digitalization
Your software development processes will seamlessly align with your ISO 13485-compliant Quality Management System (QMS), and we also offer support for QMS software implementation and digitalization to modernize your operations.
6. Customizable and Scalable Solutions
Whether you are launching an MVP, scaling to a complex platform, or entering new global markets, our development and compliance approach can flexibly scale to meet your evolving business and technical needs.
Ready to Develop Your Medical Device Software?
Whether you are a startup launching your first SaMD or an established manufacturer expanding your portfolio, we help you accelerate development while ensuring compliance.
Contact us today to discuss your medical device software project.