FDA-mandated design controls require thorough verification and validation testing of your medical device.  We can show you how to integrate the testing with your project workflow to maximize the benefits to your R&D team and minimize the risk of delays before product launch.

Verification and Validation Testing:   Designing test plans   Writing test protocols and test reports   Hardware and software testing   Developing new testing techniques and tools:       - data analysis with Matlab       - image analysis with Matlab Systems Engineering:   Writing and refining product requirements   Performing hazard and risk analyses   Compiling requirements-to-test traceability matrices   Systems integration   Interfacing with outsourced engineering

Integrated Compliance Engineering

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