Engineering Services such as Design, Process & Software Validation, QMS for Medical Devices pertaining to USFDA/CE Regulations - IZiel Healthcare

CASE STUDIES

Case studies on various types of projects completed by the IZiel team for Class I, II & III medical devices.

Process Validation

Software Validation

USFDA Approval

Complaints Handling

Acquisition Integration

MDD-MDR Transition

Fixture Design

IVDR

BLOGS

June 20230

Literature Search and Study

Clinical evaluation in healthcare involves assessing the safety and effectiveness of medical interventions or devices in humans. This process requires a thorough literature search to collect relevant...

October 20220

What is Post-Market Clinical Follow-up?

PMCF study is carried out for CE certified medical devices that are placed in the market. It’s a method of proactive collection of clinical data to analyze the emergent risks/side-effects of the...

October 20220

What is Clinical Evaluation?

It is the process to generate clinical evidence to establish the safety and efficacy applicable to all the classes of medical devices. The Clinical Evaluation should be drafted with the help of MEDDEV...

September 20220

What is Post Market Surveillance?

Post-sale of medical devices, it is critical to monitor how efficiently the device is working, its downtime, any faulty findings, any risk it poses to the users, end-users etc. In short, continuous...

WHITE PAPERS

Post-Market Surveillance & Medical Device Regulation

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Fixture Design

Services:

Welding Fixtures
Body in White (BIW)
Checking Fixtures
Machining Fixtures
Relationship Gauge Design
Special Purpose Machinery (SPM)

Projects:

Welding Fixture of Rail and Floor Assembly for Trucks
Robotic Cell Layout for Scooter Assembly Process Line
Welding & Checking Fixtures for Front Frame, Rear Frame and Full Frame for 2 Wheelers
Welding Fixture for Swing Arm of Scooters / Motorcycles
Inspection Fixture for Inner Door Panel & Underbody
Leak Testing Machine for Engine Cylinder
Fitment of Oil Ring in the groove of the Piston

CAD

Services:

3D Modelling
Legacy Conversion
Parametric Modelling
Detailing / Manufacturing Drawing

Projects:

2D to 3D Conversion for Submerged Arc Furnace
3D Modelling for Engine Components
3D Modelling of Valves and Pumps
3D Modelling of the Skid Assembly
2D to 3D Conversion for Complex Casting Components

FEA

Services:

FE Modelling (2D, Hybrid, Hexa, Tetra Meshing)
Linear & Non Linear Analysis
Static & Dynamic Analysis
Contact, Failure Analysis
Noise, Vibration and Harshness Analysis

Projects:

Thermal Analysis for Valves
Stress Analysis for Welding Gun Holder
Stress Analysis for U Shaped Hook
Stress Analysis for Spring

Onsite Deployment

Services:

Placement of Design Engineers and/or Draftsman with minimum relevant experience of 2 Years

Projects:

Successfully placed more than 250 employees in Automotive, Valves, Pumps and Heavy Engineering Industries

Design

Services:

Concept Engineering & Design Automation.
Product Design & Modelling
Reliability Engineering
Product Mechanical Testing
Design Documentation aligned with regulations

Projects:

Product Design of Myonic Arm covering 80% hand movement
Ophthalmic Sponge Assembly – SPM developed to improve productivity by 300%
Boiler Design for Steam Sterilizer – Design Calculations, Modelling & Detailing as per ASME Standards
Prefilled Syringe Covers – Concept Design, Project Management for development of covers
Poka – Yoke Checking Fixture for Femur Nail (Orthopedic)

Process

Services:

Process Characterization
Equipment Installation and Qualification
Test Method Validation
Process Validation
Process Documentation aligned with regulation
Productivity Improvement

Projects:

Complete Process Validation Documentation for Class I, II & III devices
Productivity Improvement (25%) for Disposable Products using DFSS & Lean Manufacturing Methodologies
Offshore Support to US & European Customers for FAT, SAT, IQ, OQ, PQ, TMV, FMEA ensuring cost and time savings of more than 40%

Market Analysis

Services:

Voice of Customer
Unmet Needs and Barriers to Therapy Adoption
Ethnography & Needs Prioritization
Prototyping, Piloting and Conjoint Analysis
Market Development

What to Expect:

Comprehensive understanding of care delivery, reimbursement & patient care pathway
Solutions for Emerging Markets & Challenges for Market Growth
Application of Tools like:
- Customer Process Map
- Value Down Mapping
- Patient Rate Analysis
- Therapy Penetration, Adoption & Barrier Analysis

Consulting & Training

Services:

Remediation Gap Analysis
Business Process Gap Analysis
Gap Closure Consulting
Design for Six Sigma Green Belt and Black Belt Training
Lean Manufacturing Training
Custom Suite of Statistical Software and Training

What to Expect:

Expert Trainers with experience working with pioneers of DFSS
Statistically vetted outcomes for all aspects of engineering
Customized Programs and Templates for Statistical Analysis

Risk Management

Services:

Resources backed ISO 14971 based Risk Management Consulting and Support
FMEA, FTA Based Product Risk Analysis aligned to Requirements Management.
Quantitative Risk Management Expertise
Reliability Engineering expertise on ALT, HALT etc.

Projects:

Risk Management aligned with Requirements Management for a diagnostic X-Ray machines.
Risk Management for Software
Risk Management for a single use disposable product.
Robust Statistical Model based Reliability Prediction for Class II & III devices

Quality Systems & CAPA

Services:

Complete Quality System Development Consulting
Gap Analysis and Resource Backed Support to Remediate
CAPA and Compliance expertise
Documentation aligned with FDA QSR requirements.

Projects:

Quality System Gap Analysis for diagnostic imaging products, disposables, implantable products and several large and small companies.
Procedure writing for all Design, Manufacturing and Quality areas of Medical Device Product Lifecycle.
Procedure writing for Software Development Lifecycle for Nuclear Diagnostic Imaging product.

Regulatory

Services:

Regulatory expertise for 510K and Pre Market Approval
Design Validation
Process Validation
Pool of ex-FDA auditors for product approval consulting

What to Expect:

Flawless Regulatory Approvals from FDA
Design & Process Documentation aligned with regulations

Contract Manufacturing

Services:

Leading contract manufacturer in the world with manufacturing sites in the US, Costa Rica and India
ISO Class 7 and Class 8 Cleanrooms, White Room
ISO 13485 and ISO 9001 certification
FDA site registration & Japan Product Accreditation

What to Expect:

Regulated Manufacturing Set-Ups from partners
Manufacturing capabilities of Class 1, 2 & 3 Products

3D Printing

Details:

Size: 180 x 180 x 180 mm
Print Technology: FFM – Fused Filament Modelling
Extruder Type: Dual Extruder
Color: Print in 2 colors
Materials: PLA, ABS, HIPS, Wooden filaments, PET-G, Nylon and Metal filaments
Connectivity: Laptop, USB and Micro SD card

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Thank you for registering for the webinar : “Resources – Expected Outcomes, Unknown Challenges”. We will get back to you with the details shortly.

Process

Services:

Process Characterization
Equipment Installation and Qualification
Test Method Validation
Process Qualification
Process Validation
Process Improvement
Process Documentation aligned with regulation

What to Expect:

High Yielding & Cost-Effective Processes
Predictive Process Capability
Comprehensive Understanding between Process Output & Input

IZiel Group was invited at a 3-day Entrepreneurship Awareness Camp (EAC) from 16-18 Feb 2017 at Symbiosis Institute of Technology (SIT), Pune

IZiel Group was invited for Entrepreneurship Awareness Camp (EAC) at Symbiosis Institute of Technology (SIT), Pune The Entrepreneurship Awareness Camp (EAC), aimed at sensitizing students towards entrepreneurship and equipping them with basic know-how required for their startup journey. Over the period of three days the students were given exposure to ideation, business models, business plans, legal aspects for startups, etc. through a blend of expert talks and hands-on activities along with the interactive sessions with Entrepreneurs.

Design Engineer

Educational:

Education: BE-Mech
Experience: 2 yr
Skills: CAD
Industry: Mechanical

Description:

Welding Fixture of Rail and Floor Assembly for Trucks
Robotic Cell Layout for Scooter Assembly Process Line
Welding & Checking Fixtures for Front Frame, Rear Frame and Full Frame for 2 Wheelers
Welding Fixture for Swing Arm of Scooters / Motorcycles
Inspection Fixture for Inner Door Panel & Underbody
Leak Testing Machine for Engine Cylinder
Fitment of Oil Ring in the groove of the Piston

Software Validation

Services:

Resource Backed IEC 62304 based Software Validation Consulting and Support.
Requirements Writing, Training and Review Support.
Requirements Management System Implementation and Support
Software Testing Consulting and Execution Support.

Projects:

Software Validation for a diagnostic image User Interface software.
Implementation of a Requirements Management System – Cognition Cockpit.
Software Validation for a Nuclear Imaging product.

Clinical Evaluation Report

Services:

Resource backed consulting on writing Clinical Evaluation Reports for Class 2 products.
40+ physicians with various specialities available for medical expertise.

Projects:

Clinical Evaluation Report for Nuclear Imaging Product.
Clinical Evaluation Report for Class II Disposables.