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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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