Medical Device Solutions

Medical Devices

Medical Device Software Development and Testing

Modern medical devices, from small affordable consumer devices and wearables to large clinical devices, are complex. The complexity lays 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 that are proven to improve software safety and reliability. 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 Modern Software Development Challenges

Achieve compliance with IEC 62304

Achieve compliance with IEC 62304

Modern medical device 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 device approval, many device manufacturers decide to comply with IEC 62304, the most important regulatory document available for medical systems. Parasoft tools help teams achieve compliance by implementing the processes and activities specified in the standard, including rigorous requirements management and software development/testing processes.

Defend against security threats

Defend against security threats

In modern medical healthcare systems, products that are equipped with sensors can monitor the critical parameters of the patient 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 defend against the myriad of threats that are introduced with the connectivity brought by powerful IoT devices.

Develop complex, multi-layered platforms

Develop complex, multi-layered 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 kind of solutions requires large technology stacks and very experienced engineers. Parasoft makes it easier to manage these complexities and the resulting security and IoT challenges that come with modern connectivity.

Parasoft's Solutions for Medical Device Software Testing

Parasoft C/C++test is an integrated 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, organizations can reduce the cost and effort of achieving compliance. Learn more about some of these testing practices below.

Parasoft C/C++test helps users 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 2012, MISRA C++ 2008, AUTOSAR C++14, HIC++, and more.

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, with dedicated compliance reporting to make it easy for stakeholders to understand risk.

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, necessary for proving compliance, can be generated automatincally, saving teams valuable time, with the generated reports and documentation complying with the MISRA 2016 standard, which is very popular across industries.

Parasoft C/C++test detects complex runtime-like problems early in the development stage by analyzing execution paths through the code and finding potential bugs. In addition to 2200+ rules and checkers, Parasoft makes it easy for teams to verify orgnanization-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 guidelings can be fully automated to replace the manual process of compliance verification.

Parasoft C/C++test’s convenvient 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 a 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/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 not yet implemented source code.

Parasoft C/C++test can be used to execute unit tests on the host platform, target processor simulator, or on 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, as well as with real hardware. Parasoft C/C++test’s test 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 level testing, supporting all of the coverage metrics typically required when developing safety-critical software (i.e. statement, branch, MC/DC, function, call, path, simple condition, line, block).

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/method, or specific test case.

Parasoft integrates with the team’s Requirements Management System 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 results.

Traceability reports provide clear and complete information about development progress, and 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, and 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.

Parasoft's solutions for medical device software

Benefit from the Parasoft Approach

Reduce the cost of developing high-quality software, without sacrificing time-to-market.

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Medical Device Software Compliance
RELEVANT RESOURCE:

Medical Device Software Development: Following FDA Guidelines for Software Validation

For clear compliance efforts moving forward, we provide a point-to-point index of FDA principles and the Parasoft capabilities that support them.

Parasoft tools teach our development team better coding habits. We are able to get our product to market approximately 6 months sooner with Parasoft solutions than we could have if we had gone back to the testing vendor.

- Bovie Medical

Why Parasoft?

Parasoft enables full automation for cost-effective software delivery. From static analysis to fully-automated test environments, Parasoft provides the automated software testing tools you need to ensure enforcement of compliance as a part of your DevOps workflow, integrated with an analytics platform that streamlines the reviews and audits of software delivery.