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Post-market Clinical Follow-up (PMCF) Survey

PMCF surveys provide an effective solution for legacy medical devices with limited clinical data. Unlike traditional methods such as literature reviews and registries, PMCF surveys target diverse patient populations, track follow-up data, and gather comprehensive insights more efficiently.

Learn how PMCF surveys can save time, reduce costs, and deliver robust EU-MDR compliant data, making them a superior alternative to traditional registries.

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    Why MedTech Manufacturers should Opt for PMCF Surveys?

    Surveys are a valuable tool for conducting PMCF because they can be used to collect data from a large number of patients or users. This data can be used to identify any potential safety or performance issues with the device, and to make sure that the device is still meeting the needs of patients.

    There are a number of reasons why medical device manufacturers must opt for PMCF surveys for EU MDR compliance. These include:
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    Surveys are a cost-effective way to collect data on a large number of patients or users.
    Surveys can be conducted quickly and easily, which is important for meeting the deadlines set by the MDR.
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    Surveys can be tailored to specific needs of the device and the target population.
    Surveys can be used to collect a variety of data, including information on patient satisfaction, device performance, and potential safety issues

    The MDR requires manufacturers to conduct PMCF activities that are proportionate to the risk of the device. For low-risk devices, surveys may be the only PMCF activity that is required. For higher-risk devices, surveys may be used in combination with other PMCF activities, such as clinical studies.

    Why Cetas Healthcare PMCF Surveys ?

    Cetas Healthcare has extensive experience helping European medical device manufacturers with high-quality data capture to comply with the MDR Medical Device regulations, among others. Our team of experts can help you design and execute your PMCF Report! Check out our Clinical & Regulatory Services for more information.

    Enhancing Legacy Device Data Collection with PMCF Surveys

    Overcoming Legacy Device Challenge
    Legacy medical devices, renowned for their effectiveness, often struggle to collect real-world data due to their long market presence and evolving clinical practices. PMCF surveys offer a proactive solution by directly gathering insights from patients and healthcare professionals.
    Bridging the Data Gap
    PMCF surveys act as a vital bridge, capturing feedback from legacy device users through methods like questionnaires, interviews, and observational studies. This comprehensive approach provides a holistic view of device performance, user experiences, adverse events, and patient satisfaction.
    Ensuring Regulatory Compliance
    PMCF surveys align with FDA and EU MDR regulations, allowing manufacturers to demonstrate compliance while addressing potential issues. Robust data collection methods validate legacy device performance, ensuring ongoing regulatory approval and building trust with stakeholders.
    Optimizing Device Performance
    PMCF surveys gather real-world data on legacy device performance, facilitating improvements in usability, safety, and patient satisfaction. Manufacturers can adapt devices to meet evolving healthcare needs using insights from these surveys.
    Elevating Patient Outcomes
    By actively engaging with patients and healthcare professionals, PMCF surveys identify risks, usability challenges, and opportunities for enhancing patient safety and well-being. They enable evidence-based decision-making and continual device refinement to improve patient outcomes.

    The Only Partner You'll Need From Conception to Completion

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    Design PMCF/PMCF Survey Plan

    Real World Evidence / Data Collection

    market-research

    Analysis of Survey Data

    PMCF Evaluation Report

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    NB Liaison

    See Our Clinical & Regulatory Services Portfolio Here

    4 million pre-qualified and recruited HCPs and our team of 100+ MedTech experts.

    Our PMCF surveys take just 12-14 weeks to complete, with over 5000 patient forms submitted to the NB in 2022 alone.

    Avail Offer Today!

    Avail Offer Today!



      At our core, we're driven to aid medical device manufacturers in accessing cost-effective means to gather substantial real-world evidence via PMCF surveys.

      The Only Partner You'll Need From Conception to Completion

      business-plan

      Design PMCF/PMCF Survey Plan

      Direction Arrows

      Real World Evicence / Data Collection

      Direction Arrows
      market-research

      Analysis of Survey Data

      Direction Arrows

      PMCF Evaluation Report

      Direction Arrows
      communities-social

      NB Liaison

      See Our Clinical & Regulatory Services Portfolio Here

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      In the rapidly evolving landscape of medical devices, ensuring patient safety and product effectiveness is of paramount importance. Post-Market Clinical Follow-up (PMCF) surveys have emerged as a powerful tool for gathering real-world data and insights,

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      The fusion of market research and regulatory considerations can provide valuable insights and help medical device manufacturers make informed decisions when choosing a market for their product launch. Here’s how the combination of these two

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