IZiel Healthcare
Medical Equipment - Pune, Maharashtr, IN
IZiel Healthcare Employees
IZiel Healthcare Senior Management
IZiel Healthcare Details
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 ControlsProcess & 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 ExpertiseQuality 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 RemediationTraining- Training – DFSS Methodologies and Engineering Topics
IZiel Healthcare Technologies
CMS
WordPress.org
Tag Management
Google Tag Manager
Hosting
Blue Host
CSS and JavaScript Libraries
Bootstrap Framework
Other
Mobile Friendly
Analytics and Tracking
Google Analytics