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    Support for IVDR compliance from classification to documentation.

    ISO 13485:2016 Consulting

    Implement and maintain an ISO 13485-compliant quality system.

    ISO 14971 Risk Management Consulting

    Ensure effective risk management aligned with ISO 14971.

    Biocompatibility Documentation Consultancy

    Develop and maintain biocompatibility documentation with expert support.

    Post Market Surveillance (PMS) Consulting

    Set up and manage PMS plans to monitor device performance.

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  • Services

    MDR (Medical Device Regulation) Consulting

    Expert guidance to achieve full MDR compliance efficiently.

    IVDR (In Vitro Diagnostic Regulation) Consulting

    Support for IVDR compliance from classification to documentation.

    ISO 13485:2016 Consulting

    Implement and maintain an ISO 13485-compliant quality system.

    ISO 14971 Risk Management Consulting

    Ensure effective risk management aligned with ISO 14971.

    Biocompatibility Documentation Consultancy

    Develop and maintain biocompatibility documentation with expert support.

    Post Market Surveillance (PMS) Consulting

    Set up and manage PMS plans to monitor device performance.

    Post Market Clinical Follow up (PMCF) Documentation Consulting

    Create compliant PMCF plans and reports with professional guidance.

    Registration Strategy Consulting

    Plan and execute global registration strategies effectively.
    All Services
  • About Us
  • Resources
  • FAQ
  • Contact
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+382 68 682 766
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Got questions? Call us 24/7!

+382 68 682 766
130 Oktobarske Revolucije, 81000, Podgorica, Montenegro

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  • MDR (Medical Device Regulation) Consulting
  • IVDR (In Vitro Diagnostic Regulation) Consulting
  • ISO 13485:2016 Consulting
  • ISO 14971 Risk Management Consulting
  • Biocompatibility Documentation Consulting
  • Post Market Surveillance (PMS) Consulting
  • Post Market Clinical Follow up (PMCF) Documentation Consultancy
  • Registration Strategy Consulting

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Services

  • MDR (Medical Device Regulation) Consulting
  • IVDR (In Vitro Diagnostic Regulation) Consulting
  • ISO 13485:2016 Consulting
  • ISO 14971 Risk Management Consulting
  • Biocompatibility Documentation Consulting
  • Post Market Surveillance (PMS) Consulting
  • Post Market Clinical Follow up (PMCF) Documentation Consultancy
  • Registration Strategy Consulting

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