IZiel Healthcare
Durga Kulkarni has a range of work experience in the healthcare and software consulting industries. Durga is currently serving as the Managing Director of IZiel Healthcare since 2020. Prior to this, they founded and served as the Chief Consultant of QNNOVA, a software consultancy firm specializing in regulated medical device software, starting in 2018. At Medtronic, they worked as a Software Consultant from 2018 to 2020, where they were responsible for software architecture, design, development, testing, and risk activities for dialysis products. Before that, Durga worked at Cyberonics as a Principal Software Engineer and Software Architect from 2008 to 2017, where they designed and developed software applications for a medical device used in treating epilepsy. Durga also had a role as a Senior Software Engineer at Boston Scientific from 2003 to 2008 and a Member of Technical Staff at Persistent Systems from 1999 to 2001.
Durga Kulkarni obtained a Bachelor of Engineering (B.E.) degree in Computer Engineering from Cummins College of Engineering, Pune, India in 1999. In the same year, they also completed their Bachelor of Engineering (B.E.) degree in Computer Engineering from Savitribai Phule Pune University. Later on, from 2001 to 2003, they pursued a Master's degree in Computer Science from the University of Minnesota.
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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