Case Study

Exploratory Test Validation for a Class III Medical Device

Exploratory Test Validation for a Class III Medical Device

Pages 2 Pages

Exploratory Test Validation for a Class III Medical Device Client Overview The client is one of the largest corporations in medical devices, pharmaceutical and consumer products development. Business Needs and Objectives The client sought to expedite their validation effort while maintaining standards compliance. This was part of the client’s strategic goal of reducing the development life-cycle for its medical devices. The QualiTest Solution QualiTest introduced Exploratory Test Validation (ETV), a complete test validation solution based on the Exploratory Testing approach. After a careful evaluation process, the QualiTest ETV solution was selected as the main validation approach for the project. ETV is based on Session Based Test Management (SBTM) and industry validation standards (FDA,

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