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Clinical, Regulatory and QMS Services

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    One-Stop-Shop for Your Clinical, Regulatory, and Quality Compliance Solutions

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

    Clinical Survey Applications

    Cetas Healthcare offers comprehensive clinical and regulatory services to assist medical device companies in meeting international standards. Our capabilities include developing robust clinical strategies, executing PMCF surveys, and strictly adhering to EU MDR and ISO 14155 guidelines.

    Collaborate with Cetas Healthcare, a trusted partner, to successfully guide your medical devices through the complex global regulatory environment, ensuring market access and success.

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    Our Services

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    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
      • ...

    Why Cetas Healthcare Clinical and Regulatory Services ?

    • Sample/ Panel Providers
    • ISO 14155 Compliance
    • Own panel of HCPs for PMCF surveys
    • Design MDCG-7 Compliant PMCF Survey Plan
    • Build PMCF Survey Questionnaire as per plan
    • Write MDCG-8 Compliant PMCF User Survey Report
    • Integrate PMCF Report with CER
    • CETAS Healthcare
    • ISO 14155 Compliance
    • Own panel of HCPs for PMCF surveys
    • Design MDCG-7 Compliant PMCF Survey Plan
    • Build PMCF Survey Questionnaire as per plan
    • Write MDCG-8 Compliant PMCF User Survey Report
    • Integrate PMCF Report with CER
    • Market Survey Agencies
    • ISO 14155 Compliance
    • Own panel of HCPs for PMCF surveys
    • Design MDCG-7 Compliant PMCF Survey Plan
    • Build PMCF Survey Questionnaire as per plan
    • Write MDCG-8 Compliant PMCF User Survey Report
    • Integrate PMCF Report with CER
    • CROs/ Regulatory Consultants
    • ISO 14155 Compliance
    • Own panel of HCPs for PMCF surveys
    • Design MDCG-7 Compliant PMCF Survey Plan
    • Build PMCF Survey Questionnaire as per plan
    • Write MDCG-8 Compliant PMCF User Survey Report
    • Integrate PMCF Report with CER
    • Customized Regulatory Pathway Planning

    Navigating the complex regulatory landscape requires a strategic approach. We work with you to create customized regulatory plans, guaranteeing that your medical device complies with all the necessary standards. We prepare and submit important paperwork, ensuring smooth communication with regulatory agencies to speed up product approvals.

    • Implementation of Quality Management Systems

    Compliance with international quality standards is crucial. Our expertise lies in designing and executing Quality Management Systems that suit your organization’s requirements. This includes creating standard operating procedures, conducting internal audits, and ensuring your processes align with the latest regulatory requirements.

    • Proactive Post-Market Surveillance

    Maintaining the safety and performance of your devices post-market is essential. We offer services such as complaint handling, adverse event reporting, and the development of Post-Market Surveillance Reports. Our team also designs and executes Post-Market Clinical Follow-up plans to assess device performance and patient safety continually.

    • In-Depth Regulatory Intelligence

    Staying informed about regulatory changes is vital for strategic planning. We provide insights into global regulatory trends, conduct impact analyses on your product portfolio, and offer strategic advice for market entry and expansion. Our services ensure you remain compliant and competitive in the evolving medical device landscape.

    Our Regulatory and Clinical Services Team Leads

    Sumit-Mehta

    Sumit Mehta

    Designation

    Founder & Chief Executive Officer

    Experience

    22 years in MedTech

    Sector

    Medical Technology and Life Sciences

    Profile

    Sumit is the founder of Cetas Healthcare and comes with a strong track record in Medical Technology...

    Read Detailed Profile
    Prem Pandey

    Prem Pandey

    Designation

    Head of EU MDR Compliance

    Experience

    10 years in Healthcare Research

    Sector

    Medical Technology, Life Sciences

    Profile

    Prem is a PMCF manager at Cetas Healthcare and has several years of experience in...

    Read Detailed Profile

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