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Description
More Areas of Expertise • New product and process development • Design and development of respiratory devices • Diagnostic, monitoring, sedative and therapeutic drug delivery devices • Laparoscopic and endoscopic surgical devices • Medical device design verification and validation • Quality Systems Regulations - 21 CFR Part 820 QSR, ISO 9000 / ISO 9001 / ISO 13485 • Regulatory approval process for Class I and Class II medical devices • Surgical staplers, skin stapling devices • Oxygen Concentrators • Oxygen Conserving Devices • Sleep Apnea and CPAP devices • Spirometry, Spirometers and Flow Sensors • Compressed Medical Gas Storage and Delivery • Failure mode effect and criticality analysis • Incident Investigation and Root Cause Analysis • Failure analysis • Forensic Engineering • Forensics Investigation Support • Quality Function Deployment • Conjoint Analysis • Project Management • Patent evaluation and valuation • Financial Engineering • Reliability Engineering • Statistical Quality Control • Concurrent Engineering • Design for manufacturing and assembly • Manufacturing process planning • Capacity Planning • Logistics planning • Operations Management Qualified as an expert witness in civil and criminal courts. Dr. Izuchukwu has more than two decades of experience in designing biomedical devices. He understands the limitations and performance boundaries of medical devices, and is familiar with the health and safety standards regulating them. A multi-disciplined engineer with doctor of mechanical engineering degree, he specializes in medical devices and manufacturing processes, focusing on product liability and intellectual property cases. His expertise includes design failure analysis, failures involving mechanisms, components and materials of medical systems, reliability engineering and product reliability analysis. As an expert witness, Dr. Izuchukwu represents both defendants and plaintiffs. Visit Dr. Izuchukwu website for more information.
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