IZiel Healthcare
Aniket Chaudhari is a seasoned professional with extensive experience in functional management and engineering within the healthcare and manufacturing sectors. Currently serving as a Sr Functional Manager at IZiel Healthcare since July 2016, Aniket focuses on resource allocation and optimizing utilization. Previous roles include Sr. Engineer at LG Electronics, where responsibilities encompassed production operations and interdepartmental coordination, and production planning and shop floor management at Bosch India, emphasizing quality delivery and logistics. Aniket's educational background includes an MBA in Operations and Supply Chain Management from SVKM's Narsee Monjee Institute of Management Studies, along with an M.Tech in Automobile Engineering and a BE in Mechanical Engineering.
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IZiel Healthcare
IZiel Healthcare is an Engineering & Regulatory Services provider working successfully for global medical device manufacturers from our offices in USA & India. Our engineers are trained as per Design for Six Sigma – Black Belt Level and have completed various projects in Design, Process Validation, QMS Documentation, Regulatory Approvals & Acquisition Integration for Class I, IIa, IIb & III Products. We leverage statistical & data-driven methods, domain knowledge & robust work planning methodology to achieve an optimized product development processes for guaranteed success. IZiel Healthcare provides services in: Design - Systems Engineering and Requirements Management - Transfer Function Development - Predictive Engineering - 3D Modelling & Finite Element Analysis (FEA) - Design Controls Process & Software Validation - PVMP - IQ, OQ, PQ - Test Method Validation (TMV) - Productivity Improvement - Software Validation (IEC 62304) Risk Management - ISO 14971 based Risk Management - FMEA and FTA Based Product Risk Analysis - Quantitative Risk Management Expertise Quality Management Systems and CAPA - QMS Documentation with Procedures & Templates - CAPA (Corrective & Preventive Action) Regulatory - USFDA & CE Approvals - MDD – MDR Conversion - Clinical Evaluation Report (CER) - European Authorised Representative (EAR) Remediation - Resolve Observations (Form 483), Warning Letters etc - Product Remediation Training - Training – DFSS Methodologies and Engineering Topics