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

Company’s Keywords:

medical device design, design engineering, process development, process engineering, design validation, process validation, risk management, market development, regulatory services