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    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

    FAQs

    1. What is the importance of clinical survey applications in medical device development?
    Clinical surveys provide valuable data on device performance, safety, and user experience, supporting regulatory submissions and ongoing compliance with standards like ISO 14155 and EU MDR.
    2. Why is the transition from EU MDD to EU MDR significant for medical device manufacturers?
    The transition introduces stricter regulatory requirements, focusing on post-market surveillance, clinical data transparency, and risk management, impacting product classification and documentation.
    3. What are PMCF surveys, and why are they crucial for medical devices?
    Post-Market Clinical Follow-up (PMCF) surveys gather real-world evidence on device performance post-launch, ensuring ongoing compliance with safety and efficacy requirements under EU MDR.
    4. How does a clinical investigation plan (CIP) support regulatory submissions?
    A CIP outlines the methodology for clinical trials, including study objectives, design, and data collection methods, ensuring that the generated evidence meets regulatory standards.
    5. What is the role of regulatory strategy in medical device market entry?
    Regulatory strategy involves planning and executing activities to obtain product approvals, manage risk, and align with international standards, expediting market access and reducing compliance risks.
    6. Why is Quality Management System (QMS) implementation critical for MedTech companies?
    A robust QMS ensures that all processes, from product design to post-market activities, are documented and controlled, minimizing risks and maintaining product quality and regulatory compliance.
    7 What is the purpose of post-market surveillance (PMS) in the MedTech sector?
    PMS monitors the safety and effectiveness of devices after market launch, identifying potential risks, collecting adverse event data, and supporting ongoing regulatory compliance.
    8 How does regulatory intelligence help MedTech companies stay competitive?
    Regulatory intelligence involves monitoring regulatory updates, assessing their impact on existing products, and developing proactive strategies to address new compliance requirements.
    9 What is the impact of ISO 14155 on clinical investigations?
    ISO 14155 provides guidelines for the design, conduct, and documentation of clinical investigations, ensuring data integrity, patient safety, and alignment with regulatory expectations.
    10 How does complaint handling contribute to regulatory compliance?
    Effective complaint handling ensures timely identification of potential risks, documentation of incidents, and initiation of corrective actions to maintain device safety and regulatory adherence.
    11 Why is long-term clinical data important for medical devices?
    Long-term clinical data provides critical insights into how medical devices perform over extended periods, revealing trends in device reliability, potential safety concerns, and variability in patient responses that may not be apparent in short-term studies.
    12 How can long-term clinical data help in monitoring device safety?
    It enables ongoing assessment of potential safety issues that may arise with prolonged use, helping to identify adverse events or device degradation that could impact patient outcomes.
    13 What role do clinical surveys play in collecting long-term clinical data for medical devices?
    Clinical surveys are essential for gathering data at regular intervals, capturing patient- reported outcomes, and identifying changes in clinical status, thereby providing a comprehensive view of device performance over time.

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