Software Validation Consultants

Our strong foundation is built on competence, sound management practices and commitment to customer satisfaction. Our Textile Unit has successfully delivered more than a million meters per month through our manufacturing facilities in Pune.

Today, IZiel Group has diversified its business in the Engineering Service, Healthcare Engineering and Realty Segment. At IZiel, we maintain procedural standards for every business function of the company. Our comprehensive evaluation and monitoring system ensure effective and timely deliveries.

IZiel team includes a pool of highly qualified and diverse professionals with an optimum mix of experience and enthusiasm. Along with our in-house engineering team, we have a comprehensive network of external specialist consultants and partners whose knowledge can be accessed for a total comprehensive solution. Our team has diverse experience in various industries and are well equipped to work on international client projects.

Our facilities are well equipped with world-class communication, collaboration, and engineering infrastructure with 24-hour security and access control. The company is well positioned to offer customers the established benefits of off-shore outsourcing.

Our Values

Integrity & Trust

Build Relationships within our team and with our clients.

Competence

Build Competent Teams to deliver value added outcomes.

Walk the Extra Mile

Be an equal partner with the client to achieve their goals.

Core Team

Sarvesh Mutha Director
BE Mechanical
MS Engineering Management (USA)

Sarvesh Mutha

  • 15+ years of Entrepreneurial Experience in Engineering & Realty Industry.
  • International Experience in Finance, Strategy Development and Marketing.
Ankur Naik Director
MS Mechanical (USA)
MBA Leadership & Marketing (USA)

Ankur Naik

  • Master Black Belt - Design for Six Sigma
  • PMP Certified
  • 15+ years Expertise in the Healthcare and Automotive Industry spanning Design, Manufacturing, Quality, Regulatory and Marketing
Durga Kulkarni Director
BE Computer Science
MS Computer Science (USA)

Durga Kulkarni

  • 18 + years expertise with global top 10 manufacturers for Class I, II, III medical devices in USA & India.
  • Expertise in Software Architecture, Design, Development, Validation & Testing
  • IEC 62304 & 82304 Compliance
  • Risk Identification and Mitigation
Asavari Dandekar Director
BE Computer Science

Asavari Dandekar

  • 20 years with GE Healthcare, Philips and Medtronic
  • Expertise in Product Development & Engineering Leadership.
  • Agile Transformation for Medical Software, IEC62304 & IEC 82304 Compliance
  • PMP & SAFe Certified
Todd Johnson Director – Technical Services
BE – Chemical Engineering
MBA (USA) PMP & ASQ Certified

Todd Johnson

  • DFSS Master Black Belt
  • 20+ years’ experience with Global Top 10 Medical Device companies in USA
  • Expert in Product Design & Development, Manufacturing, Quality Assurance, Predictive Engineering, Commercial Business Management.
Al Kelly Director – Business Development
BA - Business Administration
Associate Degree - Electromechanical Technology

Al Kelly

  • 30 years of experience in delivering customized Engineering Solutions to Global Medical Device Companies
  • Expertise in Product Development & Engineering Leadership
  • Extensive International and Domestic Sales Management & Marketing of Medical Devices
Dhananjay Namjoshi Design Consultant
BE Mechanical

Dhananjay Namjoshi

  • 27 + years in Mechanical & Mechatronic Industries
  • Expertise in Product Development, Process Automation Special Purpose Machines, Material Handling, Fixture Development & Problem Solving
Rohit Mittra Business Development Head
PG – Ancient History
Gold Medallist - Sales Leadership Program

Rohit Mittra

  • 40+ years’ experience in Business Development for Diabetes, Cardiovascular & Orthopaedics.
  • Expertise in Execution & Sales Force Effectiveness.
Vilas Phule Finance Controller
Chartered Accountant (CFA)

Vilas Phule

  • 40+ Years of experience in Finance, Accounting for Engineering Industries.
  • Strategy Development to achieve Organization’s Projected Growth
  • Expertise in developing Financial & Strategy Models to align with Organizational Goals.
Aniket Chaudhari Process & QMS Expert
BE Mechanical Engineering
M. Tech Automobile Engineering

Aniket Chaudhari

  • Hands on experience on Productivity Improvement - Lean Tools like VSM and VSD, Heijunka, Kaizen, Kanban, Pull System, TPM
  • Knowledge of Six Sigma Tools: Process Capability, SPC, Gauge R&R, Regression Analysis
  • Expert in Quality Management Systems 21 CFR 820, ISO 13485 and ISO 14971
Ritam Verma Senior Engineer
MS Biomedical (USA)

Ritam Verma

  • 5+ Years global experience Cook Medical, Integer (USA)
  • Expertise in ISO 13485, 14971, ISO/IEC 62366-1, EU- MDR, USFDA Certified Auditor (ISO 13485:2016)
  • Expertise in FDA 21 CFR 7, 11, 801, 803, 806, 807, 814, 820, 821, 822 & 830
Deeksha Hegde Quality & Regulatory Affairs Specialist
B.E Biotechnology

Deeksha Hegde

  • 6+ years of global regulatory experience in Medical Device Industry.
  • Expertise in Regulatory Filing, Gap Analysis, Facility Compliance Audits Mock Audits, Establishment Registration and Device Listing.
  • Excellent knowledge of EU MDR, 510(k), Risk Management (ISO 14971)
Chitra Sreekumari Sr. Project Manager
MS - Biomedical Instrumentation

Chitra Sreekumari

  • 15+ years Project Management for Medical Device Product Development Lifecycle
  • Expertise in Requirement Management, Product Documentation, Clinical Evaluation & Regulatory Approvals (FDA, CE, CFDA).
  • Experience in Interventional Radiology, Software – Oncology, Patient Monitoring, Ortho Surgery.
Manasi Maheshwari QARA Specialist
MS - Pharmaceutical Management, USA
PG - Diploma in Quality Assurance, Mumbai
BSc - Microbiology, Mumbai

Manasi Maheshwari

  • 11 years of global experience in Quality & Regulatory Compliance in US, UK and India.
  • Worked in Biotechnology, Blood transfusion and Clinical Research Industry.
  • Expertise in Quality Management System Implementation. Proficient with CLIA, CAP, GCP and GTP environments.
Sagar Shinde Business Development Manager
Diploma in Pharmacy
PGDM in Sales and Marketing

Sagar Shinde

  • 17+ years experience in Pharmaceutical Sales and Marketing
  • Skilled in Marketing Strategy, Customer Relationship Management (CRM), and Strategic Communications