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IEC 62304
IEC 62304 Compliance and Tools
Ensure compliance with IEC 62304 for medical device software development using Parasoft’s comprehensive testing solutions. Streamline your software life cycle processes to achieve compliance efficiently with automated tools.
IEC 62304
What Is IEC 62304?
IEC 62304 is an international standard defining the software development life cycle requirements for medical device software. It emphasizes the development of safe and reliable software through risk management, documentation, and systematic processes to ensure patient safety.
Satisfy IEC 62304
Adhere to stringent software life cycle requirements, manage risks effectively, and ensure patient safety by mastering the development, verification, and validation processes outlined in IEC 62304.
IEC 62304 Software Compliance in the Medical Industry
Learn about the important role of the IEC 62304 functional safety standard in developing medical software and software in medical devices. Discover how automated testing accelerates compliance.
Benefits Parasoft Brings to IEC 62304
Automate critical processes such as static and dynamic analysis, requirements traceability, and code coverage to achieve compliance with IEC 62304. Parasoft’s solutions reduce development costs, improve software reliability, and streamline certification efforts.
Static Analysis
Identify potential errors, vulnerabilities, and standard violations early in the development life cycle with Parasoft’s static analysis for coding standards like MISRA, CERT, and more. Ensure compliance with IEC 62304’s emphasis on robust and safe coding practices.
Ensure Compliance With Functional Safety Standards | Get compliance support from Parasoft through various testing methods, including requirements traceability and compliance report generation. Such methods ensure safe, secure and reliable C and C++ applications. |
Static Analysis Security Testing (SAST) - IEC 62304 | Integrate compliance with security coding rules and guidelines from standards such as CWE, CERT, OWASP, and MISRA into your static analysis processes. This ensures robust software security for safety-critical systems. |
Control Flow Analysis - IEC 62304 | Identify potential execution paths through a program and track control movement. This enables the detection of dead code or logic. It also finds flow-related issues critical to satisfying compliance. |
Data Flow Analysis - IEC 62304 | Identify vulnerabilities such as uninitialized variables, injection flaws, and unsafe data handling in electronic systems with sensors, control logic, actuators, and microprocessors that require software Class A-C safety integrity requirements. |
Walkthroughs and Inspections | Enhance static analysis with walkthroughs or our Code Review module. Automate preparation, notification, and tracking. This ensures efficient reviews align with the standard’s requirements for independent assessment and traceability. |
Test Smarter With AI and ML | AI and ML enhance static analysis workflows. Teams can automate the prioritization of critical issues. Generative AI explains and suggests fixes for static analysis violations to streamline compliance efforts. |
Dynamic Analysis
Automate the execution of tests to detect issues during runtime. This is essential for satisfying validation needs. Parasoft’s software testing framework for C and C++ supports unit testing, integration testing, system testing, and more. Teams can also take advantage of popular frameworks like GoogleTest.
Unit Testing | Isolate units with automated stubbing frameworks and mocks to validate behavior across various inputs. Doing so ensures compliance with IEC 62304 safety integrity levels. |
Generate Test Cases Automatically | Generate test cases automatically to cover edge cases and error conditions to reduce manual effort. This also increases test coverage to ensure that every line of code is inspected. |
Structural Code Coverage | Satisfy 100% code coverage requirements with Parasoft’s support for statement, branch, and MC/DC code coverage. Ensure testing of all code paths to meet safety objectives. |
Requirements Traceability - IEC 62304
Automate bidirectional traceability between requirements, test cases, test results, the source code, and code reviews to satisfy risk management objectives. Maintain alignment with IEC 62304’s focus on life cycle documentation and the requirements traceability matrix.
Compliance Reporting
Automatically track progress toward IEC 62304 compliance with dynamic dashboards. Generate reports to demonstrate compliance and address audits. Gain visibility into testing outcomes, even for large or legacy codebases.
Incorporate Static and Dynamic Analysis Into Your CI/CD Workflow
Integrate seamlessly into CI/CD pipelines with Parasoft’s static analysis, unit testing, regression testing, code coverage, and requirements traceability. Teams can also incorporate most of these capabilities into testing frameworks like GoogleTest to ensure reliable, safety-compliant software that aligns with IEC 62304.
Tool Qualification
Our C/C++ testing solutions have been TÜV SÜD certified according to IEC 62304 across all software class levels. The compliance certificate satisfies IEC 62304 requirements. No further action is needed. However, if you desire, we offer a tool qualification kit that automates the process. You can perform tool qualification within your development ecosystem.
Solutions to Help Meet IEC 62304 Objectives
C/C++test
C/C++test is a comprehensive, automated software testing solution for safety-critical applications. It integrates seamlessly into CI/CD pipelines and IDEs. Static analysis, dynamic analysis, requirements traceability, code coverage and report generation ensure that your software satisfies verification requirements defined in IEC 62304.
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C/C++test CT
C/C++test CT automates code coverage and requirements traceability for systems requiring IEC 62304 compliance. It streamlines V&V activities by integrating with testing frameworks like GoogleTest, CppUTest, and UnitTest++, along with CI/CD pipelines.
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DTP
Parasoft DTP aggregates test results and requirements traceability to ensure compliance with IEC 62304. The dynamic dashboard provides visibility into gaps and testing progress, supporting iterative safety assessments.
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Insure++
Detect memory problems, runtime errors, and security vulnerabilities such as buffer overflows and memory leaks. Insure++ enables proactive identification of memory allocations and deallocations that could affect medical device safety, ensuring alignment with IEC 62304.
Learn MoreWhy Parasoft?
Get unique advantages for compliance through our comprehensive solutions. By automating critical processes like static and dynamic analysis, requirements traceability, and structural code coverage, our solutions ensure efficient and reliable verification of safety-critical medical device software. Our solutions integrate seamlessly into existing development environments. Teams streamline workflows and accelerate compliance efforts.
Dedicated Integrations
Simplify development workflows for complex medical device software systems. Integrate Parasoft’s solutions with embedded IDEs and debuggers. Supported environments include Eclipse, VS Code, QNX technology, Green Hills MULTI, Wind River Workbench, and more.
System-to-System Testing for Functional Safety
Use Parasoft SOAtest and Virtualize for system-level testing. Teams can automate functional API testing and stabilize dependencies to accelerate IEC 62304 compliance activities.
Time and Cost Savings
Parasoft’s solutions help reduce the time and cost of compliance with IEC 62304 by automating labor-intensive tasks and providing targeted insights.
On-Target Hardware Software Testing
Ensure accurate and reliable software performance when it’s integrated with actual hardware. Use our C/C++ testing tools to test the software on the actual target hardware. This is a must for detecting hardware-specific issues, validating assumptions, and meeting requirements for real-world medical devices.
Frequently Asked Questions
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