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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++ testing solutions provide an integrated software testing solution for medical device development, automating a wide range of software testing practices specifically tailored 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.

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++ testing solutions 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 and C/C++test CT 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.

Parasoft C/C++test CT is in the process of TÜV SÜD certification and a Quality Kit is being developed.

stars

“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