Software Testing
Independent Verification
CriTech provides a variety of software testing services, from development of plans, designs, test cases, and procedures to test execution and reporting. We offer complete independent verification of the software for your product.
Throughout the testing, we follow a proven IEEE-based verification process that results in documentation that aids technology transfer to the customer at the end of the project.
Intended-Use Validation
Intended-use validation confirms and documents that a specific software application or system produces the intended or specified results aligning with FDA guidance and international standards such as ISO 13485 and IEC 62304. We develop and execute intended-use validation procedures for software-based tools used in the development and manufacturing of medical devices. We also offer this service for software contained within the device itself.
Our methods include Automated and Manual Testing, Regression Testing, Usability and Human Factors Testing, and Risk-based Testing approaches aligned with industry standards.
