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    IEC 62304

    In today's world software is an integral part of medical device technology. Determining the safety and efficacy of a medical device that contains software requires the utmost attention during development.

    Therefore, software quality assurance tools need to reliably  meet the highest standards of the medical industry, e.g. comply with IEC 62304. You can ensure this by using our static and dynamic testing tools. 

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    Development of Medical Device Software According to IEC 62304 up to Severity Class C

    IEC 62304 is the international standard for medical device software development and other medical device software life cycle processes. It refers to the maintenance and safe development of software that is either Software as a Medical Device (SaMD) or Software in a Medical Device (SiMD).

    IEC 62304 defines three severity levels:

    • Class A: No injury or damage to health is possible
    • Class B: Non-serious injury is possible
    • Class C: Death or serious injury is possible

    As the security and quality of software can literally be a matter of life and death in the medical sector, reliable analyses and sustainable testing are mandatory for software projects in the medical field.

    Our sophisticated tools Squish, Coco, Test Center, Axivion Static Code Analysis and Axivion Architecture Verification help you to check your software up to severity level C.

     

    How to Comply with IEC 62304?

    Our portfolio enables you to develop the most innovative and safe applications for the medical industry.  We help you meet the requirements of IEC 62304 up to the severity level class C. To meet this medical safety standard, the tools involved in the development and testing of software require to prove that they are suitable for use in safety-critical environments. The Tool Qualification Kits for our Quality Assurance solutions are designed to do just that.

     

     

    Axivion

    Axivion is a premium architecture verification and static code analysis tool, which identifies violations of coding guidelines and standards at an early stage. It also detects clones, cycles or unreachable code to ensure the quality of your software. Axivion Static Code Analysis is certified by SGS-TÜV Saar GmbH as suitable for use in the development of safety systems according to the requirements of IEC 62304 up to Class C.

    Read More About Axivion

    Tool Qualification Kit for Axivion

     

    Squish

    Developing safety-critical software requires reliable testing of a components. Squish is a cross-platform, automated GUI testing tool for virtually any desktop, mobile, web or embedded platform. It supports the testing activities outlined in IEC 62304, which require to include requirements-based testing, functional testing, and risk-based testing. In addition, Squish also fully supports Behaviour-Driven Development (BDD).

    Read More About Squish

    Tool Qualification Kit for Squish

     

    Coco

    This 3-in-1 tool for code metrics, coverage analysis and profiling is feature-rich, flexible and easy to integrate into virtually any toolchain. Coco's dynamic analysis optimise the efficiency of your testing protocols and reach new levels of product quality. It discovers untested or redundantly tested code, locates dead code and also computes the optimal order of test executions to maximise coverage.

    Read More About Coco

    Tool Qualification Kit for Coco

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    Medical Software Solutions

    Explore the quality assurance solutions for the medical industry.

     

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