What We Do

phinique technologies

We take of complete QMS process compliant with ISO 13485, FDA, EU MDR

Requirement to manufacturing complete product design and development.

Understanding the end use requirements from clinical perspective & compliance standards, R&D and designing of product as per these requirements.

  • Complete medical devices development support from clinical need to R&D to manufacturing. We have expertise in R&D , design and development and process development of minimal invasive-Peripheral, Cardiovascular, Neurovascular devices.
  • Complete support for CAD and drawing creation, Geometric dimensioning and tolerancing, Tolerance stack up.
  • Design for manufacturing.
  • Tooling development, co-ordination with vendors for getting parts developed and verified as per design requirements.
  • Specialized in Plastic, Sheet metal component design, Electromechanical
    systems integration.
  • Our team have understanding and implementation experience of medical
    devices standards and regulations.

Prototyping, 3D printing

Complete support for Prototyping of designed products, functional and performance assessment of prototype products, understanding gap from prototyped product and implementing same for next revision if required.

  • Implementing design changes based on prototype findings, making
    design iterations and verify it.
  • 3D printing, aluminium machining, sheet metal work for prototyping of
    plastic and metal parts.

Verification, Validation, Testing

Making and executing verification and validation plan for complete
product, sub systems and parts.

  • Risk analysis, FMEA’s , Risk management.
  • Develop test methods based on clinical scenarios and testing on bench.
  • Verification and validation of test methods through statistical methods – gauge R&R.
  • Test reports, Verification, Validation report.
  • ISO and Regulatory testing.

Process Development

We Design and develop process to meet product requirements.

  • Process validation and qualification.
  • PFMEA, Process risk management.
  • We are expert in processes like Injection moulding, Casting, Sheet metal, Welding, Polymer extrusions.
  • Process automation, design and development of customized fixtures for
    your processes.

Fixture design and development for customized applications & process automation

Understanding test and process requirements, designing and
developing fixtures as per these requirements.

  • Complete automation for testing and process needs.
  • Process automation to improve quality, minimize variations
    and improve efficiency

Statistical analysis

Statistical data analysis for test and process data.

  • Test method development and validation – gauge R&R.
  • DOE – DOE planning , statistical analysis and conclusion.
  • Use of statistical tools like Minitab, Design expert.
  • Analysing production data for root cause analysis.
  • Design for six sigma.

Quality management system – ISO 13485 and FDA, EU MDR

We create and maintain all regulatory documentation like Design control, FMEAs, Risk matrix, Part and product requirements, Design history file etc for FDA and EU MDR.

  • ISO 13485 , 21 CFR documentation.
  • Manufacturing , process development, process qualification
    documentation.
  • Creating and maintaining Quality management system- QMS
    system.

Engineering Services across domains

CAD design and drawing services for automobile, construction, manufacturing industries.

  • Plastic , Sheet metal component designs and prototyping.
  • Injection moulding tool design and development.
  • Jig and fixtures design and development, manufacturing.
  • Process automation and test automation design and development.

Engineering Staffing and training, project management

Complete end to end product design and development training.

  • Staffing of trained engineers for your projects.
  • Complete project management, resource management.

Our product design portfolio

We have expertise in design and development of medical devices right from user needs, clinical needs to verification and
validation, regulatory submissions.

Products

We have expertise in design and development of medical devices right from user needs, clinical needs to verification and validation, regulatory submissions.

>Neurovascular catheters >Cardiovascular catheters >Peripheral catheters >Braided structures - Stents

Interventional

All catheters in above therapy  Micro catheter , Guide catheter , Support catheter, Aspiration catheters and Balloon catheters

>CPAP
>BiPA
>Ventilators

Respiratory

All kind of respiratory products for
Sleep Apnoea and respiratory support

>Single use scopes
>Hypotubes

Endoscope

Endoscopes, non-vascular products, and process design.

>Single use scopes
>Hypotubes

Consumable and Surgical Products​

Laparoscopy devices , Syringe, sheath etc

Meet Our Experts

Team's Shout Out

Our team comes up with 20+ years of R&D and product development experience. We would like to be partner in you medical device product development journey. Our expertise will definitely reduce your development time and cost.
Phinique Technologies
Phinique Technologies

Innovation products

We designed and developed various innovative products for specific clinical needs , Due to NDA obligations not sharing here

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