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Category Archives: Regulatory

26Oct/22

What is Post-Market Clinical Follow-up?

October 2022RegulatorySarvesh Mutha

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 theRead More…

04Oct/22

What is Clinical Evaluation?

October 2022RegulatorySarvesh Mutha

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 ofRead More…

15Sep/22

What is Post Market Surveillance?

September 2022RegulatorySarvesh Mutha

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, continuousRead More…

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Phone: +91 72762 12555

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121 Washington Avenue North, Suite 306 Minneapolis, MN 55401
Office Phone: +1 (612) 445-8764

Email: [email protected]

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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
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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
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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
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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
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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)
 
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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% 
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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
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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
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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
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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.
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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
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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
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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!

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

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

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

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

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

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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Post-Market Surveillance & Medical Device Regulation
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MDD-MDR Transition- Medica Devices

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