OUR VALUES

WHO WE ARE

IZiel Group is built on the foundation of excellence, sound

management practices and winning customer trust.

IZiel Healthcare is an Engineering & Regulatory Service

Provider working in design, process validation &

improvement, engineering documentation, software

validation, USFDA Approval and/or remediate the

observations (I483), findings from warning letters for

medical device companies.

IZiel’s approach for an Outcome-Based Delivery along with

the Cost-Effective Model by combining teams from India &

US has worked very well for customers in USA, Europe and

Asia. Our comprehensive evaluation and monitoring system

ensure effective and timely deliveries.

COMPETENCE

DESIGN PROCESS

QUALITYSYSTEMS &CAPA

RISKMANAGEMENT

REGULATORY REMEDIATION

CONSULTING & TRAINING

COLLABORATION -MANUFACTURING & MARKETING

OUR EXPERTISE

INTEGRITY & TRUST WALK THE EXTRA MILEBuild competent teams to deliver value added outcomes.

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

Build relationships within our team and with our clients.

REMEDIATION

Why IZiel Healthcare ?

• Conduct a Methodical & Comprehensive

Gap Assessment.

• Outcome Based Delivery Approach

• Partner with Remediation Experts in USA

• Quick Scalability of Skilled Resources

- Design

- Process Engineering & Validation

- Systems Engineering

- Software Validation & Testing

- QMS and Regulatory.

• Assist in complete implementation

• Flexible Onshore/Offshore Model

• Significant Time and Cost Advantages

• Strong Project Management

• Observations (Form 483)

• Warning Letters from USFDA

• Resolve product design & process

development issues

• Substantial number of unplanned

resources & budgets

• Declined opportunity to sell

What is Remediation ?

QUALITY MANAGEMENT SYSTEM

STRATEGYCREATION

GAP ASSESSMENT

DESIGN INPUTS &DESIGN CONTROLS

IMPLEMENT DATA ARCHITECTURE WITH RMS TOOL – COGNITION COCKPIT

REQUIREMENTS MANAGEMENTWRITING & TRAINING

SYSTEM VERIFICATION & VALIDATIONS

SOFTWARE VALIDATION & TESTING

CLINICALEVALUATION REPORTS

CAPA &COMPLAINTS HANDLING

FDA COMPLIANT REGULATORY FILING

DOCUMENTATION & LEGACY CONVERSION

RISK MANAGEMENT

RISK MANAGEMENT

PROCESS DEVELOPMENT & VALIDATIONS

TEST METHOD VALIDATIONS

TEAM COMPETENCY

CARDIOVASCULAR ORTHOPEDICDIAGNOSTICIMAGING

CASESTUDIES

DIABETOLOGY HOSPITALEQUIPMENTS

OPHTHALMOLOGY

IN VITRODIAGNOSTICS

• Remediation of a Diagnostic Imaging Product

- Create FDA Compliant Design, Process and Risk Management Documentation.

- Software Validation (Software and Firmware) of an Image Acquisition, Post Processing and

Systems Control Software.

- Revamp Quality Management System & provide comprehensive training

- Project Management using Onshore-Offshore Model to reduce cost and implement flexible

resource allocation

• US FDA Approval & Regulatory Strategy for Diagnostic Imaging Equipment

- IZiel Hybrid Model bringing in cultural change to complete Design History File (DHF).

- US FDA Submissions completed with India-US Teams thereby saving cost.

• Productivity Improvement for Disposable Products of a large German Manufacturer

- Adopted DFSS & Lean Manufacturing Principles alongwith Process Automation.

- Productivity increased by 25% occupying only 70% of the existing space.

• Product Design & Development for Myonic Arm

- Project Approved and Funded by BIRAC, Government of India

- Concept Design, Product Modeling & Detailing for 5 gestures covering 80% of hand

movement.

• Offshore Support to US & European Partners and Clients

- Procedure Development, Process Validation Support for FAT, SAT, IQ, OQ, PQ, TMV, & FMEA.

- Highly Competent Team ensuring Cost & Time Savings of 40% or more.

IZiel takes immense pride in our strong team, comprising

talented engineers that have worked with large medical

device manufacturers globally in the fields of design, process

improvement and validation, software validation & testing,

firmware, quality control and regulatory.

Our leaders have varied experience in medical device

development, international business, finance and academia.

IZiel team undergo comprehensive training in DFSS

(Black / Green Belt) through application workshops and

classroom training.

GENERALSURGERY

ACHIEVEMENTS

CLIENTS

10 Best Startups in Medical Devices in India, 2017.-Startup City magazine

‘25 fastest growing MedTechcompanies in India, 2017’

-CEO magazine

‘Top 20 MedTech Solution Providers in APAC - 2018.’

-MedTech Outlook magazine

Empanelled with Andhra PradeshMedTech Zone, Government of India

Work done for medical device companies through IZiel Healthcare & its partners.

• Medtronic

• B. Braun

• Disposafe

• Hospitech

• Starkey

• Heartware

• Sterisys

• Agappe Diagnostics

• Omnilens

• USM Healthcare

• Mediso Imaging

• Medicor

• Primus Sterilizer

• Skanray Technologies

• Prognosys

TRAINING &CONSULTING

Our Consulting Team in collaboration with partners can work with you to provide -

Our training is fully adhered to the medical device industry with experts having huge

experience in providing training to large medical device manufacturers. Some of the key

training modules are –

• Process Validation & Productivity Improvement Projects

• Interim or Turn Around Management for Medical Device and Pharma companies

• Adoption of V Model in organizations

• Project Management in Complex Environments

• Integration into Global Production Networks

• Consultation for the Top Management

VOICE OF CUSTOMER & REQUIREMENTS MANAGEMENT

PROCESS ENGINEERING& VALIDATION

QUALITY MANAGEMENTSYSTEMS

APPLIED STATISTICS

SOFTWARE VERIFICATION & VALIDATION

RISK MANAGEMENT

DESIGN OFEXPERIMENTS (DOE)

USFDA REGULATIONS STRATEGY & APPROVALS

DESIGN & DEVELOPMENTOF MEDICAL DEVICES

DESIGN CONTROLS

LEAN SIX SIGMAGreen Belt / Black Belt

DESIGN FOR SIX SIGMAIntroduction Green Belt / Black Belt

COLLABORATIONS& PARTNERSHIPS

COGNITION CORPORATION (USA) –

- Sole Reseller of Requirements Management Software Tool in Asian Region

- Data Migration & Implementation of Cognition Cockpit

- Training, Support, Customization of Cognition Cockpit

PRAGMATEK CONSULTING GROUP (USA) –

- Mock Audits & Trainings

- Change Management

- Product Remediation Support

MEDICAL ENGINEERING CONSULTANTS (USA) –

- USFDA Remediation to resolve findings, observations& warnings

- Manpower Placement in USA

- Onshore – Offshore Model for Engineering & Regulatory Services

AVASA EXCELLENCE GMBH (GERMANY) –

- Interim or Turn Around Management for Medical Device and Pharma plants

- Process Validation and Improvement

- Project Management in Complex Environments

- Integration into Global Production Networks

REGULATORY CONSULTANTS (USA) –

- Regulatory Partners for 510(k) / PMA Submissions for USFDA Approval

- Ex-FDA Auditors with more than 3500 + reviews and approvals

SPELLBOUND INC. (INDIA) –

- Preparation of Clinical Evaluation Reports

- 30+ National Board Certified Physicians

IZiel Healthcare is looking to collaborate or make joint ventures with organizations

abroad for distribution & manufacturing of niche products. IZiel has developed the

necessary industrial infrastructure, team and technical capabilities for manufacturing &

assembling in India. Industrial infrastructure includes a building of around 20,000 sq.ft.

with a land of approximately 100,000 sq.ft. for future expansions.

MANUFACTURING & MARKETINGCOLLABORATIONS

IZiel Healthcare has developed a strong global presence by developing

collaborations and partnerships to help medical device companies with –

• Functional Teams in USA, Europe & India

• Quick Scalability

• Faster Timelines

• Lower Budgets / Costs

• Strategy & Implementation

• Local & Global Outlook

• Short Term Deployment with quick turnaround

14, Hadapsar Industrial Estate, Hadapsar, Pune 411013

Call: +91 72762 12555 | Visit: www.iziel.com