IZiel Healthcare
Medical Equipment ManufacturingView the employees at
IZiel Healthcare-
Channaveer Kumbar Engineer at IZiel Software Solutions
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Bengaluru, Karnataka, India
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Rising Star
Swati Salpekar Principal at IZiel Healthcare-
Pune
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Top 10%
Rashmi Thakur Associate QARA Specialist- IZiel Healthcare | Medical Devices- NIPER-M'23 | Pharma-NPC'21-
Pune, Maharashtra, India
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Rising Star
Kaivalya Prasad Experience in Medical Device Regulatory Affairs (EU-MDR) and PSUR-
Mumbai, Maharashtra, India
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Rising Star
Overview
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
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