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Using Vector Tools for Medical Software Certification to IEC/EN 62304

Meet the verification requirements for every safety class without the testing workload taking over your schedule. See how VectorCAST and PC-lint Plus help.

Download the White Paper

IEC 62304 requires more verification evidence as your safety class rises, and producing it by hand is where medical software schedules slip. This white paper shows how PC-lint Plus, VectorCAST, and other Vector tools automate that work, from unit testing through coverage, so your team spends less time proving compliance and more time building.

Meet IEC 62304 Verification at Every Safety Class

Unit Implementation

Automate Unit Testing and Traceability

PC-lint Plus automatically enforces your coding standards, while VectorCAST runs requirement-based unit tests and preserves traceability.

Integration Testing

Verify Your Interfaces and Risk Controls

VectorCAST verifies software interfaces and confirms that your risk control measures hold up. Through requirement-based and robustness testing, you can rerun on demand.

Test Execution

Reuse Tests Across Different Targets

VectorCAST runs the same tests on the host, a simulator, or the embedded target and reports the structural coverage required by IEC 62304 without rework.

Key Visual Code Verification Testing Dark HD

Capture the Code Coverage IEC 62304 Requires

As safety classes rise, so does the level of structural coverage you must demonstrate. VectorCAST captures every level the standard requires, whether on the host, a simulator, or the embedded target.

Statement Coverage

Every line of code has been executed at least once.

Branch Coverage

Every decision has been tested both true and false.

Modified Condition Decision Coverage - Unit Testing

MC/DC Coverage

Modified Condition / Decision Coverage ensures every condition independently affects its decision's outcome; this is the most rigorous level.

Certified Software Tool

The VectorCAST product family is TÜV SÜD certified for safety-related development.

Trusted for FDA Submissions

Teams use VectorCAST to demonstrate due diligence in meeting FDA software quality requirements across Class I, II, and III devices.

Get the White Paper

Fill out the form below to receive the complete IEC 62304 tool mapping, with every objective matched to a Vector tool.

Using Vector Tools for Medical Software Certification According to IEC/EN 62304

VectorCAST White Paper

Version 2.0 | October 2026

Using Vector Tools for Medical Software Certification According to IEC/EN 62304 - White Paper

What's Inside

Why process assurance replaces product assurance in safety-critical software
Complete IEC 62304 safety classification table for Classes A, B, and C
Objective-by-objective tables mapping each activity to a specific Vector tool
Where PC-lint Plus, VectorCAST, and other Vector tools fit across the IEC 62304 verification lifecycle