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


Engineering

Health Care

Medical Devices

IZiel Healthcare

Ankur Naik

Sagar Shinde

Madhura Mengade

Sarvesh Mutha

Durga Kulkarni

Asavari Dandekar

IZiel Healthcare

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