IEC 62304 Compliance for Medical Device Software with CppDepend

IEC 62304 defines the software life-cycle requirements for medical device software. It classifies software into safety classes A, B and C according to the severity of potential harm, and requires documented architecture, coding standards, unit implementation and verification, plus rigorous configuration management. Notified bodies and the FDA expect objective, repeatable verification evidence.

What IEC 62304 Means for Your C/C++ Code

• Software architecture documentation: the architecture must be described, maintained and verified against the implementation.
• Coding standards: Class B and C software must follow documented coding standards with tool-supported enforcement.
• Unit verification: code reviews alone are not enough — objective criteria, coverage and static analysis results are expected.
• Problem resolution: anomalies must be tracked, analyzed and demonstrably resolved.

How CppDepend Supports IEC 62304 Teams

• Architecture-as-code: dependency graphs and DSMs give you living architecture documentation that always matches the implementation.
• Coding standard enforcement: built-in MISRA C/C++ and CERT C/C++ rule sets, plus custom CQLinq rules for your internal guidelines.
• Regression control: baseline comparisons prove what changed between releases — essential for change analysis under §7 and §8.
• Objective quality evidence: complexity, coupling and debt metrics exported as part of the verification record.
• Audit-ready reporting: timestamped reports for design reviews and regulatory submissions.

Related Industries & Case Studies

• Case study: IEC 62304 compliance in embedded medical devices
• Case study: safety in embedded firmware

Related Coding Standards

ISO 14971 · MISRA C · CERT C++ · IEC 61508