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MEDICAL DEVICE TESTING - SAFETY AND EFFECTIVENESS

Sigma Biomedical supports medical device companies, providing product safety testing and risk management in various areas as required by the FDA for product approvals. Testing and product safety services include the following:

Ultrasound/Acoustic Testing
Electrical Safety
Material Characterization
Software V&V
Doppler Sensitivity Measurements
Measurement Accuracy
Risk and Hazard Analysis
Risk Management
Failure Mode Effects Analysis FMEA


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FDA, Regulatory, consulting, medical devices, 510(k), ultrasound, acoustic output, QSR, testing, safety, effectiveness, MDD, medical device directive, federal drug administration, SVV, software verification and validation, compliance, data acquisition, medical imaging, telemedicine, ultrasonic, machine vision, quality control, wireless monitoring, signal processing, signal analysis, data analysis, flow meter, position sensing, diagnostic ultrasound, electronic records, medical images, particle detector, bubble detector, noise, vibration, control, evoked potentials, accoustic output, acustic output,