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Skills

  • Medical Device Design
  • Medical Device Development
  • Medical Device
  • Documentation Services
  • ISO 13485
  • Licensing Consulting
  • Design
  • Design Verification Testing
  • Management
  • Planning
  • Quality Assurance
  • Quality Assurance Management
  • Regulatory Audits
  • Risk Assessment
  • Usability Engineering

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Services

  • Medical devices regulatory

    $15/hr Starting at $150 Ongoing

    Dedicated Resource

    I provide the medical devices consulting by providing the services for CE marking, 510 k, ISO 13485, 21 CFR part 820 implementation, Medical devices manufacturing unit design, Design and development documentation...

    ISO 13485Medical Device DesignMedical Device DevelopmentRegulatory AuditsValidation Engineering

  • CE marking

    $15/hr Starting at $2K Ongoing

    Dedicated Resource

    We provide the services for the technical file Preparation assist through all the process of CE marking process for medical devices and PPE.

    Documentation ServicesMedical DeviceMedical Device DesignMedical Device DevelopmentRisk Assessment

  • 510 k

    $15/hr Starting at $1K Ongoing

    Dedicated Resource

    I provide services for 510 k of medical devices, Testing requirements, creation of submission, communication with USFDA, query responses for getting 510 K. Also we assist in Establishment registration...

    Medical DeviceMedical Device DesignMedical Device Development

  • ISO 13485

    $15/hr Starting at $1K Ongoing

    Dedicated Resource

    I provide the consulting for ISO 13485, I provide templates of SOPs, Modulate the SOPs, Provide training for ISO 13485 and also help implementation of ISO 13485 along with assistance in audit

    ISO 13485Medical DeviceMedical Device DesignMedical Device Development

  • DHF creation

    $15/hr Starting at $1K Ongoing

    Dedicated Resource

    We provide the services of the documentation. of design and development of medical devices, This includes design planning, design input, design output, design verification and validations and compilation...

    DesignDesign Verification TestingDocumentation ServicesMedical DeviceMedical Device Design

  • Clinical evaluation

    $15/hr Starting at $700 Ongoing

    Dedicated Resource

    I provide services for creating the clinical evaluation documentation as per CE marking requirements

    Documentation Services

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About

To provide one stop solution for medical devices manufacturer.

We Operon Strategist provide the regulatory services of the medical devices., right from manufacturing unit design, product design and development, setting up quality management system, Indian FDA, USFDA and CE marking.

Founded: 2011

Work Terms

Work by taking some amount in advance and later two of three stages of payments depending on duration of work

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