IEC 62304 – Consulting for Medical Device Software (SaMD/MDSW)
Integrating IEC 62304 Compliance into Your Medical Device Software Development
At QMLogic, we provide specialized IEC 62304 consulting services to ensure your medical device software (SaMD/MDSW) meets international regulatory standards. Whether you're preparing for IEC 62304 certification, CE Marking, or FDA approval, we guide you through every phase, from process design and risk management to technical documentation and audit readiness. Our approach emphasizes practical, agile-compatible solutions that support modern software development, including cloud infrastructure, incorporated CI/CD pipelines, and automated verification steps.
Why Choose QMLogic for your IEC 62304 Implementation?
Real Development Expertise
We build medical device software ourselves, so our IEC 62304 regulatory consulting services are based on firsthand development and audit experience, not just theory.
Seamless Agile & CI/CD Integration
We help your team align IEC 62304 requirements with Agile methods, cloud deployment, and CI/CD automation, avoiding unnecessary process slowdowns.
Proven Track Record in Certification Audits
Our regulatory consultants have passed numerous CE marking audits, FDA inspections, and technical file reviews for medical software across various global markets.
Customized Regulatory Consulting
We offer flexible regulatory compliance consulting, tailored to your organization’s software development practices, size, and risk class.
IEC 62304 Regulatory Consulting Services
IEC 62304 Implementation Consulting
We design and implement IEC 62304-compliant development processes that cover the full software lifecycle, including:
- Software Development Planning
- Requirements Engineering
- Software Design and Architecture
- Software Risk Management aligned with ISO 14971
- Verification & Validation Activities
- Release and Maintenance Procedures
IEC 62304 Compliance Consulting
Ensure IEC 62304 compliance across every development phase. Our services include:
- Gap Analysis & Process Audits
- Software Risk Classification
- Alignment with IEC 62304 software classification guidelines
- Recommendations for Agile, Cloud, and CI/CD Environments
IEC 62304 Certification Consulting
We prepare your team for:
- MDSAP & Global Market Approvals
Includes preparation and review of:
- Technical Documentation (Design, Development, Architecture, V&V, Risk Management, Maintenance)
- Traceability Matrices for Design Controls and Risk Management
IEC Technical Documentation Consulting
Clear and compliant documentation is essential for IEC 62304 certification. We support:
- Software Architecture Documentation
- Risk Management Files and its connection with the Software Life Cycle
- V&V Specification and Reports aligned with agile development
- Maintenance and Software Problem Resolution Plans
- Automated CI/CD Integration
Related Medical Device Regulatory Consulting Services
As part of our integrated services for medical device manufacturers, we also offer:
ISO 13485 Quality Management System Consulting
See moreISO 14971 Risk Management Consulting
See moreQMS Software Implementation Services
See more