IZiel Healthcare

About

IZiel Healthcare is an Engineering, Software & Regulatory Services provider working successfully with 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

Keywords

medical device design, design engineering, process development, process engineering, design validation, process validation, risk management, market development, regulatory services, software validation, cybersecurity, gobal medical device manufacturers

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