Medical Devices

Medical Device Software Development Testing

Modern medical device software products, from small affordable consumer devices and wearables to large clinical devices, are complex. The complexity lies in several areas. Most notably, the formal process required to approve the device for use, the numerous security threats that must be defended against, and the complexities that come with the multilayered platforms that are used to develop medical device software.

Parasoft’s integrated toolkit for C​ /C++​, ​Java,​ and .​ NET​ applications support a broad range of best practices for medical device tests that are proven to improve software safety, reliability, and user experience. Static analysis and unit/component testing, with comprehensive code coverage analysis, requirements traceability, and tool qualification kits​ will help you reach compliance with the quality expectations of IEC 62304.

Address Today's Medical Device Software Testing Development Challenges

Achieve Compliance With IEC 62304

Modern medical software development organizations need to make sure their devices will be approved by certification authorities such as the FDA. To reduce the risk, cost, and effort related to medical device approval, many medical device manufacturers decide to comply with I​EC 62304​, the most important regulatory document available for medical systems. Parasoft tools help teams achieve compliance with regulations by implementing the development process and activities specified in the standard, including rigorous requirements management and software development and testing processes.

Defend Against Security Threats

In modern medical healthcare systems, products that are equipped with sensors can monitor the critical parameters of the patient’s health and send that information to a system in the cloud, where automatic analysis is made and critical alerts can be emitted or drug administration changed. Parasoft helps organizations interested in testing medical software defend against the myriad of security threat events that are introduced with the connectivity brought by powerful IoT devices.

Develop Complex, Multi-Layered Technical Platforms

Organizations developing connected medical devices often face platforms that include a collection of disparate technologies — from low-level sensors based on microcontrollers and programmed in C, up to server-level systems supported with huge databases and running AI-based algorithms to detect dangerous patterns in patient’s health parameters. Implementing these kinds of solutions requires large technology stacks and very experienced engineers. Parasoft medical device tests make it easier to manage these complexities and the resulting security and IoT challenges that come with modern medical device software connectivity.

Parasoft's Solutions for Medical Device Software Development Testing

Parasoft C/C++test is an integrated software medical device development testing solution for automating a broad range of software testing practices for C and C++. By automating the testing practices required by functional safety standards such as ​IEC 62304,​ medical organizations can reduce the cost and effort of achieving compliance. Learn more about some of these medical device tests below.

Parasoft C/C++test helps medical device testing labs achieve code compliance with coding standards by providing the industry’s largest set of built-in code checkers, verifying compliance with standards such as MISRA C 2023, MISRA C 2012, MISRA C++ 2008, AUTOSAR C++14, HIC++, and more.

“MISRA”, “MISRA C” and the triangle logo are registered trademarks of The MISRA Consortium Limited. ©The MISRA Consortium Limited, 2021. All rights reserved.

For organizations focused on mitigating the risks of security threats in their medical devices, Parasoft C/C++test promotes secure coding patterns and helps users achieve compliance with security coding standards. Parasoft C/C++test’s support for security coding standards is the most comprehensive solution on the market with built-in checkers for verifying compliance with standards such as CERT C, CERT C++, UL 2900, CWE, and others. Dedicated compliance reporting makes it easy for stakeholders to understand risk management.

To reduce the cost of complying with coding standards, Parasoft’s dedicated reporting enables users with granular, dynamic views into the compliance process. Parasoft’s centralized reporting system helps users make sense of testing results by analyzing code violations according to the groupings and categorizations from the original standard.

Compliance documentation, which is a must for proving compliance, can be generated automatically. The generated reports and documentation complying with the MISRA 2020 standard, which is very popular across industries, saves teams valuable time while boosting performance.

Parasoft C/C++test static analysis tool detects complex runtime-like problems early in the development stage by analyzing execution paths through the code and finding potential bugs. In addition to 2500+ rules and checkers, Parasoft makes it easy for teams to verify organization-specific coding guidelines with a special editor for creating custom checkers to extend (or replace) the built-in rules provided with the tool. With Parasoft C/C++test, users don’t have to write any scripts, and organization-specific coding guidelines can be fully automated to replace the manual process of compliance verification.

Parasoft C/C++test’s convenient views and graphical editors reduce the manual effort of unit test case creation and maintenance with a unit testing framework designed with safety-critical software testing in mind. Stubs and test cases with values for tested software’s stimulation can be created as source code or with graphical editors with source code generation capabilities.

Users can store and review created test artifacts together with the project’s files. The initialization of the variables and input parameters for tested software stimulation is done in exactly the same way as during production software operation, making the method reliable and robust.

Unit testing is much easier and productive if used together with a stubbing and mocking framework. Parasoft C/C++test’s powerful module for creating stubs and mocks help in fault injection testing, reduce dependencies of the tested code, and enable users to easily stub out source code that hasn’t been implemented yet.

Parasoft C/C++test can be used to execute unit tests on the host platform, target processor simulator, or the embedded target. This flexibility enables developers to run tests frequently inside the IDE and in the CI/CD pipeline, where simulators are typically used with real hardware. Parasoft C/C++test’s testing harness was optimized to take minimal additional overhead for the binary footprint and processor cycles. Dedicated integrations with embedded IDEs and debuggers make the process of executing unit test cases smooth and automated.

Parasoft C/C++test displays code coverage results from all levels of testing, including unit, integration, and system. It supports all of the coverage metrics typically required when developing safety-critical software (statement, branch, MC/DC, function, call, path, simple condition, line, block, and more).

Parasoft users spend less time analyzing coverage results to find gaps in the testing process. Developers can review code coverage results inside IDE with dynamic views and filter the results depending on metric, function and method, or specific test case.

Parasoft integrates with the team’s requirements management system (RMS) to provide traceability reports that display the correlation between requirements and the following:

  • Source code created to implement these requirements.
  • Test cases created to test the requirements.
  • Results of executed tests and code coverage.

Traceability reports provide clear and complete information about development progress. Teams can easily determine how many requirements were already implemented and how thoroughly they are tested.

Parasoft C/C++test is certified by TÜV SÜD as suitable for use when developing safety-critical software. For projects with a higher level of risk, Parasoft C/C++test’s qualification kit automates a significant part of the tool qualification process, reducing the amount of manual work and eliminating this distraction from software teams.

A dedicated qualification support tool guides users through all of the steps required to qualify the tool. It automates the majority of the tedious manual work required to qualify the tool, including executing the test cases from the exhaustive test suite provided and generating the final reports required to document the qualification process.

Benefit From the Parasoft Approach

Reduce the cost of developing high-quality medical device software without sacrificing time-to-market thanks to integrated medical device tests.

Benefit From a Unified Tool With Multiple Medical Device Testing Practices

Parasoft C/C++test satisfies multiple software testing requirements enumerated in IEC 62304. The comprehensiveness of the solution translates into lower learning and setup effort. Developers don’t have to learn several tools and can focus on their core activities. Tool integrators or architects can save time otherwise spent on implementing interfaces between the tools for exchanging the data and generating uniform reports.

Advanced Reporting

Parasoft C/C++test connects to Parasoft’s integrated reporting server for team-wide data integration, convenient reporting, and advanced analytics from Parasoft’s Process Intelligence Engine (PIE). These sophisticated analytics are more useful because Parasoft correlates information from multiple sources, such as source code or requirements management systems, testing tools, or ALMs, helping users focus efforts in the most productive way. In addition to increasing productivity by monitoring trends in the development process, users can also generate reports that comply with industry standards, i.e. “MISRA Compliance: 2020” documentation.

Get Everything You Need for Tool Qualification

Parasoft C/C++test is certified by TÜV SÜD for use when developing software compliant with IEC 62304, and supported with a Qualification Kit for software classified with higher risk classes. Parasoft’s dedicated Qualification Support Tool guides users through all the steps required to qualify the tool and automates the majority of the tedious manual work required, including executing the test cases from the exhaustive test suite and generating the final reports required to document the qualification process.

“Every time we are going to release a new software version of the Ventway Sparrow ventilator, we make sure that the static analysis from Parasoft is configured to run according to the FDA regulation definitions. We not only noticed improvements in code quality, but C/C++test has really helped us in our static analysis verification activities and goal of achieving FDA 510k certification.”

- Inovytec