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31stSeptember 2023

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    Post-market Clinical Follow-up (PMCF) Survey

    The EU Medical Device Regulation (EU MDR) is a new set of regulations that govern medical devices’ production and distribution in Europe. The EU MDR requires more stringent clinical evidence for medical device manufacturers than previous guidance (Directive 90/385/EEC, Directive 93/42/EEC). As a result, many medical device manufacturers will need to collect more evidence proactively via clinical investigations or post-market clinical follow-up (PMCF) activities to obtain and renew their Conformitè Europëenne (CE) Mark certifications.

    Collecting high-quality data is the goal for any clinical study, and PMCF Studies are no exception. The key is to rely on excellent guidance and sound technology. Since a PMCF Report can include data from various sources, manufacturers should include exact steps for data capture that comply with EU Medical Device Regulation requirements and the respective authorities.

    PMCF Survey - Avail Offer Today

    To get a risk-free experience of Cetas Healthcare expertise, we'd like to offer you a FREE review of one PMCF survey plan or questionnaire.



      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?

      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 services for more information.

      PMCF Surverys

      The Only Partner You'll Need From Conception to Completion

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      Design PMCF/PMCF Survey Plan

      Real World Evicence / Data Collection

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      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

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        The fusion of market research and regulatory considerations can provide valuable insights and help medical device manufacturers make informed decisions

        Contact us for Cetas Healthcare PMCF Surveys

          We provide the best insights for your business