FDA-mandated design controls require thorough verification and validation testing of your medical device.  We can show you how to integrate an efficient, risk-based test program 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 Software validation compliant with FDA guidance and IEC 62304 Developing new testing techniques and tools Calculating sample sizes for given reliability and confidence levels Data and image analysis with MATLAB Providing test results for regulatory submissions Systems Engineering: Writing and refining product requirements Performing hazard and risk analyses, compliant with ISO 14971 Compiling requirements-to-test traceability matrices Designing product development plans; software development and validation plans Writing risk management plans and reports Training client staff in design controls and test engineering techniques

Integrated Compliance Engineering

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