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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. |
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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
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Integrated Compliance Engineering |
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408-930-5245 |
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