IZiel Healthcare
Kathia Ruiz Cano has experience working as a Project Engineer at IZiel Healthcare and as an Ingeniero de Manufactura at Viant Medical. Kathia also served as a Practicante de Ingeniería Biomédica at Hospital General de Tijuana, where Kathia conducted maintenance on medical equipment, inventory checks, and provided support in operating rooms. Additionally, Kathia worked as a NPI Manufacturing Engineer and NPI Manufacturing Engineering Support Specialist at Jabil Healthcare.
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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