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

Sarvesh Mutha

Durga Kulkarni

Asavari Dandekar

The Engineering team at IZiel Healthcare is responsible for handling the engineering aspects of medical device product development. This includes systems engineering, transfer function development, predictive engineering, 3D modelling, finite element analysis (FEA), and ensuring robust design controls. The team leverages their expertise to manage and optimize the design process, ensuring the highest quality and compliance with global regulatory standards for medical devices. Their roles encompass various stages of product development and validation, including process validation, risk management, and software validation, all aimed at delivering safe and effective healthcare solutions.

Leadership Team

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Engineering

About

Team members

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Engineering

About

Team members

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