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Whitepaper
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Medical device manufacturers must demonstrate consistent compliance with FDA requirements and customer expectations across the entire product development lifecycle—from design through provisioning. Standard ISO 13485 establishes organizational best practices for quality assurance, while IEC 62304 provides a framework for safe medical device software development.
Modern medical devices face increasing software complexity and competitive pressure from consumer electronics companies entering healthcare markets. CI/CD and DevOps practices help manufacturers reduce costs and accelerate time-to-market while maintaining quality.
Software test automation is essential—integrating static analysis, unit testing, and code coverage into the CI pipeline dramatically improves efficiency and software quality.
Automating the build and deployment process is essential for true continuous integration, as manual methods are too slow and tedious. While CI relies on a single code repository and automated builds to quickly resolve integration issues, a major bottleneck occurs at the testing phase.
Testing is time-consuming and difficult to scope, a problem worsened by manual methods. Although test automation is crucial, the whitepaper argues that simply running automated tests is insufficient, a point it promises to explore further.
In medical device software development, CI/CD adoption faces unique challenges beyond typical application development, including strict safety and reliability requirements, decades-long product lifecycles, and embedded hardware constraints. Specifically, automated testing is difficult due to the complexity of running and observing tests on target devices and the need for traceability and compliance data.
Solutions like Parasoft C/C++test address these barriers by offering an optimized test harness with minimal footprint, source code customization, and integrations with embedded compilers and IDEs. This enables automated regression testing, behavior verification, and remote execution, allowing medical device teams to achieve the automation benefits seen in other fields while meeting rigorous regulatory standards.
Testing medical device software is time-consuming, especially regression tests required after any change. Automation of regression test suites provides significant time and cost savings.
Parasoft C/C++test provides an optimized test harness with minimal binary footprint, delivered as customizable source code for platform-specific modifications.
The solution offers dedicated integrations with embedded compilers (GNU GCC, IAR, ARM, Intel, Keil, Wind River, Green Hills) and industry-standard IDEs (Eclipse, VS Code, Green Hills Multi, Wind River Workbench, IAR EW, ARM MDK). It supports creation of regression testing baselines that automatically verify all outcomes, running tests automatically to detect functionality changes.
Containerized deployments are becoming standard for medical device development teams managing complex toolchains. Teams struggle with synchronizing upgrades, reacting to security patches, ensuring toolchain consistency, versioning environments for certified products, supporting audit requirements, and onboarding developers.
Parasoft C/C++test Professional configures easily to work with compilation toolchains and execution environments deployed in containers. The tools deploy with a single compressed archive to simplify container initialization, supporting Linux and Docker containers.
As a command-line tool, it fits in-container deployments, packaged with compiler and build system for CI/CD and local scans. The tool accesses containerized compilers (GNU GCC) and runtime environments with separate Docker containers for compiler/build tools and execution environment.
Bugs are exposed earlier where they can be fixed easier and more cheaply. Finding defects early in the development cycle reduces cost exponentially compared to late-stage discovery.
New features can be tested to see how they impact existing code. New tests are added to the regression test suite after each iteration, building comprehensive validation.
The product improves incrementally by adding and testing new features while removing bugs. Quality and security are built in through incremental fashion rather than bolted on at the end.
Continuous testing and delivery are essential parts of the continuous development process. Integration alone isn’t effective without continuous testing and delivery components.
The shift-left approach integrates quality, safety, and security testing early in development to fix issues when they are cheaper and less risky. This requires building quality in from the start. Key recommendations for enabling it in CI/CD include improving test automation, increasing code coverage, automating bidirectional traceability, and monitoring all commits.
While crucial for CI/CD quality and security, test automation’s biggest challenge is selecting what to test, as exhaustive testing is unsustainable. To accelerate the pipeline, teams must strategically automate only the tests that maximize code coverage and verify changes, enabling efficient, continuous testing.
Code coverage measures how much production code executes during automated tests. Based on classification, the medical device software could require statement, branch, and MC/DC (modified condition/decision coverage) metrics to ensure comprehensive validation.
Parasoft’s Coverage Advisor uses advanced static code analysis (data and control flow analysis) to find values for input parameters required to execute specific uncovered code lines. It computes preconditions for function parameters, global variables, and external function calls, presenting solutions for user-selected lines. These values create new unit test cases, boosting developer productivity working on unit tests to improve coverage.
Requirements traceability is the ability to describe and follow the life of a requirement in both forwards and backwards directions through development, specification, deployment, and ongoing refinement. Traceability keeps track of exactly what you’re building—ensuring software does what it’s supposed to and you’re only building what’s needed.
Many medical device software requirements are derived from safety analysis and risk assessment. The system must perform intended functions and mitigate risks to reduce injury possibility. Documenting and proving these safety functions are implemented and tested fully requires traceability.
Maintaining traceability records at any scale requires automation, particularly important in CI/CD pipelines since manual traceability would slow each iteration. Integrated software testing tools complete verification and validation by providing automated bidirectional traceability to executable test cases, including pass/fail results tracing to source code implementing requirements.
Continuous quality in CI/CD pipelines requires monitoring all inputs into the software build. When developers check in code after making changes, it triggers the CI pipeline, resulting in compile, build, and test cycles. If code doesn’t meet coding standards or tests fail, the code/branch doesn’t merge into master branch, maintaining code quality at all times for master branch.
DevSecOps methodologies share automation and continuous processes with DevOps for establishing collaborative development cycles. DevSecOps shifts security to the left, which is crucial for embedded safety- and security-critical software.
Modern DevSecOps initiatives require assessing risks associated with release candidates instantly and continuously. Continuous testing within CI/CD pipelines provides automated, unobtrusive immediate feedback on security risks, guiding development teams to meet security requirements and helping managers make informed trade-off decisions to optimize release candidates.
Continuous integration and delivery plays a crucial role in medical device development. Migrating a waterfall process to CI/CD and agile development pays off with risk reduction and quality and security improvements. Security is top of mind for medical device developers and CI/CD enables DevSecOps, introducing security requirements and controls into all aspects of the pipeline.
Containers are a perfect fit with CI/CD, supporting rapid deployment and portability across different host environments with versioning and centralized control. Containerized development environments are important for secure development in DevSecOps pipelines since it’s possible to provide a reproducible application environment with built-in security controls.
Testing is by far the most time and resource consuming activity in medical device development. Continuous testing is a necessary component of a well-oiled CI/CD pipeline and provides a framework to shift testing earlier in the life cycle. With the right application of automation and focus on the highest risk areas, it’s possible to streamline testing to be less of an inhibitor in continuous processes. Continuous testing requires tool support for automation and optimization—tools that drive larger code coverage, smart test execution, and bidirectional traceability.
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