Clinical and Regulatory Services

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    Achieve State-of-the-Art Compliance for Your Medical Device Regulatory Requirement

    Our Services

    PMCF Survey Execution for EU MDR compliance

    • PMCF plan
    • PMCF survey plan including statistical analysis plan
    • ...

    EU MDD to EU MDR transition

    • Gap Analysis (MDD to MDR)
    • Summary of Technical Documentation Preparation
    • ...

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    Clinical Strategy/Support

    • Clinical Strategy & Consulting
    • Clinical Investigation Plan (CIP)/Investigator Brochure (IB) preparation
    • ...

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    Clinical Literature Review

    • Systematic Screening of Relevant Data
    • Background Literature Review (SOTA)
    • ...

    EU MDD Support

    • STED preparation
    • Updating PMS with the PMS Plan, PMSR (Only for Class I), PSUR, PMCF Plan, and PMCF report PMS
    • ...

    Regulatory Strategy / Support

    • Strategic Regulatory Consulting
    • Regulatory Operations Support
    • ...

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    QMS Strategy / Support

    • Procedures, Work Instructions, SOPs, Templates creation
    • QMS Transformation – EU MDR Compliance
    • ...

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    PMS Strategy / Support

    • Complaint Handling; Adverse Event Reporting
    • Post Market Surveillance Reports (PMSR), Post Market Surveillance Update Reports (PSUR) Preparation
    • ...

    Our Regulatory and Clinical Services Team Leads

    Contact us for Cetas Healthcare Clinical and Regulatory Services

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