Lal Kattil

Summary: 28 years of experience in Medical device Industry. Currently working as System Compliance Engineer for Karl Storz Imaging. Karl Storz - FDA 510k submissions, EMC test engineering activities, System level Regulatory compliance activities and Risk management activities for Endoscope camera devices CAREFUSION: Design verification testing (DVT), Compliance testing, Infusion Pump V&V , Infusion pump Server management software testing, Lab management BAXTER: Design verification testing (DVT), Test optimization, Product Performance Qualification (PPQ) DEKA: V&V Lead for Product Performance Qualification (PPQ) test protocol, Regulatory compliance of medical devices GE HEALTHCARE: Hardware design test protocols, Reliability testing for ECG machines GE POWERCONTROLS: Design and construction of test fixtures for verification of magnetic components like transformer and inductor DANAHER: Software quality for a dental imaging software L&T: Manufacturing manager in electrosurgical unit production line for 9 years Experience in EMI/EMC/Safety/FCC Compliance testing for medical devices as per IEC standards Specialties: Medical device Verification and Validation Medical device software Testing Medical device EMI/EMC Medical device regulatory and compliance Medical device Risk analysis activities