Welcome to Meditix Solutions
+91 88844 48072    info@meditixsolutions.com
Meditix Solutions

About Meditix

  • Meditix solutions private limited established in June 2018 for the purpose of aiding medical device manufacturers in their regulatory processes and product certifications.
  • We offer end-to-end guidance to help your product to market.
  • Our expertise has hands-on industrial experience in medical device industry.
  • We are ISO 13485:2016 certified service provider with a scope for provision of Professional services in global regulatory to medical device manufacturers.
  • We solve your regulatory needs, in the way that suits you best.
  • Our clients rely on us completely for our works and our services, which make us long term association with them.
  • Today, we are providing our consulting services to several clients across the globe and cater to their needs.
  • Logo:

    Our company logo “The modern astronomical symbol for earth with a cross (representing the equator and one meridian)” implies that we provide our compliance services worldwide and adopting and cover global current rules and regulation for medical devices.

    Our Services:

    Regulatory Compliance

    Europe

    • Complete Technical Documentation, GSPR, PSUR, Post Market Surveillance as per EU MDR 2017/745

    USA

    • Technical Dossier for 510k & PMA

    Australia

    • Common Technical Dossier as per TGA Regulation 2002

    Health Canada

    • Technical Dossier as per SOR/98-282
      Other Country Regulations as per country specific requirements

    Risk Management

    • Plan & Report as per ISO 14971

    Risk Management

    • Plan & Report as per ISO 14971

    Usability

    • Formative, Summative, Unknown provenance as per IEC 62366-1

    Compliance Testing Support

    • IEC 60601-1 & 2 and other applicable standards

    Software Development Life Cycle(SDLC)

    • IEC 62304

    Design History File

    • ISO 13485

    Preclinical Evaluation & Testing Support

    • ISO 10993-1& Other applicable standards

    Quality Management System

    • Implementation as per ISO 13485, MDSAP, 21CFR820

    Trainings

    • Third-party Audits

    Our Mission:

    Our mission is to provide Loyal service to MedicalManufacturers and Healthcare industries and to help everyone receive Quality and Safe medical devices.

    Achievement:

    Significant Progress in Performance – Excellence Award from CII India in Nov 2020

    Working Place:

    A passionate work environment and our Meditixteam members often work together, individuals treat each other with respect and company also encourages meaningful interactions between colleagues.

    Regulatory Support Towards:

    Capabilities

      
    CE Marking
      
    FDA Approval
      
    510 (K) approval
      
    Clinical Evaluation Report
      
    Clinical Investigation
      
    Post Market Clinical Follow up
      
    Usability Engineering
      
    Risk Management
      
    Quality Management System Support
      
    Audit Support
      
    Labelling as Per Regulatory Norms
      
    Compliance Testing Support
      
    Preclinical/
    Biocompatibility Testing Support
      
    Training
      
    Design Control/Validation and Verification Support