Form 483 Remediation Services to Medical Device Companies – IZiel Healthcare

Form 483 Remediation Services to Medical Device Companies – IZiel Healthcare

The efforts that any medical company puts to create a medical device or a treatment for some disease is immense but when it comes to understanding the compliances that come along with these working procedures, they face many obstacles. One of the major causes for halts in any such procedures in the United States is the Form 483 Remediation.

This compliance completely observes the procedure and the product on which the work is being conducted and if there are any substantial indications of damages and side effects the process is advised to abide by the changes that are required to make the procedure completely effective and compliance-oriented at the same time.

IZiel Healthcare is one of the best companies in this section. They help you and assist you with any such changes that can be pinned by the remediation compliances and re-construct the design for you. They have been working with all the medical companies across the globe subsequently assisting them with form 483 remediation and many other compliances with their quality understanding of the requirements and a panel of experts.

Some key features of IZiel Healthcare –

Effective Team
Expert Panel from the healthcare industry
Immediate assistance with the compliances and remediation
Cost-Effective

Fixture Design

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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

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CAD

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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

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FEA

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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

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Onsite Deployment

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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

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Design

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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)

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Process

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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%

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Market Analysis

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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

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Consulting & Training

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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

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Risk Management

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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

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Quality Systems & CAPA

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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.

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Regulatory

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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

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Contract Manufacturing

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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

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3D Printing

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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!

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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.

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Process

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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

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

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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.

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Design Engineer

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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

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Software Validation

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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.

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Clinical Evaluation Report

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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.

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