Free Trial

Comprehensive Support for IEC 62304

IEC 62304:2006, along with Amendment 1:2015, defines life cycle processes for medical device software based on safety class. ECLAIR helps satisfy key requirements across all classes:

  • Development planning and verification (5.1.1 – 5.1.11)
    ECLAIR supports planning activities through built-in coding standards, metric analysis, and automated verification services.

  • Software requirements management (5.2)
    ECLAIR’s requirements tracing guarantees bi-directional traceability between code, requirements, and tests.

  • Software architecture and segregation (5.3)
    ECLAIR Independence Checker enforces architectural rules and interface separation, which is critical for ensuring safe decompositions.

  • Unit verification and integration testing (5.5 – 5.6)
    ECLAIR verifies that unit-level implementation complies with required coding standards (e.g., MISRA, BARR-C) and expected metric thresholds.

ECLAIR COVERAGE OF IEC 62304

Supporting FDA’s General Principles of Software Validation

ECLAIR addresses key validation requirements in the FDA GPSV guidance:

  • Requirements traceability
    Traceability is ensured at all levels with ECLAIR requirements management tools, which connect software artifacts with system-level specifications and tests.

  • Defect prevention and lifecycle planning
    ECLAIR enables static verification of source code early in development, reducing defect injection and supporting life cycle process conformance.

  • Change impact analysis
    Differential analysis and reproducible builds allow developers to assess the full impact of changes and validate modifications effectively.

  • Tool support for independence and automation
    Automated checks via ECLAIR enable partial independence from the development team and support repeatable validation activities.

Coding Standards and Architectural Enforcement

ECLAIR supports all the main software coding standards relevant to medical software:

  • MISRA C:2025 and earlier versions, enforced via the MC package.

  • MISRA C++:2023 and MISRA C++:2008, supported by the MP package.

  • BARR-C:2018, included in all ECLAIR packages.

In addition, ECLAIR supports advanced architectural verification and segregation enforcement through ECLAIR Independence Checker, helping justify software item classification in accordance with IEC 62304’s principles.

Qualification for Use in Safety-Related Projects

ECLAIR has been independently certified by TÜV SÜD as suitable for use in the development of safety-related software, in compliance with the prescriptions of:

  • IEC 61508 – up to SIL 4
  • ISO 26262 – up to ASIL D
  • EN 50128 – up to SIL 4
  • EN 50657 – up to SIL 4
  • EN 50716 – up to SIL 4
  • IEC 62304 – all software safety classes (A, B, C)
  • ISO 25119 – up to SRL 3

For projects requiring tool qualification, ECLAIR offers tailored solutions:

  • ECLAIR FuSa Pack, all-in-one package to leverage TÜV certification in your project.
  • ECLAIR Qualification Kits, detailed documentation, test suites, and procedures.
  • ECLAIR Qualification Service, full qualification support by BUGSENG experts.

Aligning with the European Medical Device Regulation (MDR)

The MDR, effective from May 2021, requires medical device software to be developed in accordance with state-of-the-art standards, explicitly referencing life cycle management, information security, verification, and validation.

ECLAIR enables you to meet these expectations by:

  • Applying proven coding standards that embody industry best practices.

  • Enforcing interface segregation and architectural constraints.

  • Providing complete traceability and validation artifacts.

ECLAIR helps ensure that your development process is defensible, compliant, and aligned with the MDR’s safety expectations.

Designed for Excellence in Medical Software Development

ECLAIR is built for flexibility, scientific rigor, and precision:

  • Extensively validated with industrial and proprietary test suites.

  • Based on research in software verification and static analysis.

  • Configurable to your development process, environment, and objectives.

ECLAIR is the solution of choice when correctness, compliance, and patient safety cannot be compromised.

Learn More

If you are developing safety-related medical software, learn more about how ECLAIR can accelerate your path to IEC 62304 and FDA GPSV compliance

View resources 

Schedule a Call with Our Team