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Tool Qualification Solutions

Tool Qualification Solutions

Many regulatory agencies require that any software tool used to tailor the safety life-cycle must be qualified to ensure that the tool is functioning correctly for the intended purpose.  Genuen’s Tool Qualification Kits (TQK) provide a solid foundation for achieving formal qualifications used as part of your development process in highly regulated industries such as automotive, aerospace and medical.

Compliance for Highly-Regulated Industries

Genuen‘s Tool Qualification Solutions provide a huge step forward in compliance with regulatory directives. 



DO-178C, DO-254, DO-330



ISO 26262



EN-5128, EN-5129

Test Planning


IEC 62304, 21 CFR 820



IEC 61508

Tool Qualification Kits

Medical device software

Tool Qualification Solutions


Challenges of Formal Tool Qualification

Formal tool qualification enables tools to be trusted as true and correct, eliminating the need for costly, time consuming and recurring manual review of the tool outputs. 

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Benefits of COTS Solution

The Tool Qualification Kit provides documentation that will be needed for regulatory compliance with the overall goal is to show  transparency for the qualification process.


Save Time and Money

By eliminating the need for manual verification, our kits provide value to companies across a wide variety of safety and mission critical industries where rigorous product development processes demand the highest levels of assurance. 

Tool Qualification Solutions

Genuen’s Qualification solutions provide a solid foundation for achieving formal qualification for software tools that are used as part of the development process in highly regulated industries like automotive, aerospace and medical.