Parasoft: Your Medical Device Code Passed. What Went Untested?

Parasoft provides software verification and test automation tools that combine code analysis, automated testing and coverage measurement for embedded medical-device software. It addresses the difficulty of checking increasingly complex code that must operate within hardware, memory and timing constraints. Defects and untested execution paths can be difficult to detect through manual review alone, while maintaining links between requirements, code and test results adds further development overhead.

Its C/C++test product uses static analysis to identify defects and security vulnerabilities without executing code, then applies AI assistance to explain findings and suggest fixes. AI-assisted unit-test creation helps expand test suites, while C/C++test CT supports coverage-gap analysis for frameworks such as GoogleTest and helps identify additional test conditions. This approach combines deterministic analysis and measured test results with AI-generated suggestions, keeping engineers responsible for reviewing proposed changes and verifying their effects.

Within development workflows, these capabilities can reduce repetitive test-authoring work and shorten the process of investigating findings or closing coverage gaps. Connected analysis results, test evidence and requirements traceability also make verification status easier to review as software changes. The practical benefit is a more informed assessment of testing completeness and less manual reconciliation of evidence, rather than a guarantee of defect-free software or improved clinical outcomes.

Last checked on October 27, 2026: Parasoft’s latest listed product announcement adds MISRA C++:2023 TC1 support, following its June 2026 expansion of AI-assisted remediation and coverage-gap analysis.

What is Parasoft?

Parasoft provides software verification and test-automation tools for medical-device manufacturers and embedded-software engineering teams, supporting static analysis, unit testing, structural code coverage and requirements-to-test traceability. Its C/C++test and C/C++test CT products combine deterministic analysis with AI-assisted code remediation, test creation and coverage-gap analysis, including workflows for existing GoogleTest suites. The tools support verification evidence for IEC 62304 and other safety and security standards; they do not replace engineer review or establish regulatory approval of the resulting medical device.

Intended Use and Limitations

• Parasoft reports TÜV SÜD certification for the Compliance editions of C/C++test and C/C++test CT for safety-critical development, including IEC 62304 medical-device software workflows.

• Certification applies to specified tool releases and intended uses, not future versions; the certificate and supporting safety documentation are available through the customer portal.

• Parasoft offers automated tool-qualification kits to generate evidence within a customer’s development environment, supporting assessment of whether the testing tool is suitable for its intended use.

• Kitea Health publicly identifies C/C++test as its verification tool for investigational intracranial-pressure sensor firmware, providing a named MedTech deployment rather than an anonymous customer claim.

• In Parasoft’s published Kitea Health account, the customer reports 99–100% code coverage and a 25% reduction in firmware development time; these are customer-reported results, not independently validated clinical outcomes.

• Parasoft documents support for MISRA, CERT and CWE checks, providing coding-standard and vulnerability-analysis capabilities relevant to medical-device software assurance.

• Requirements traceability, structural coverage reports and verification documentation support IEC 62304 evidence preparation; these capabilities do not themselves establish FDA clearance or CE marking for a customer’s device.