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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.
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.
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.
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.
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.
Our PMCF surveys take just 12-14 weeks to complete, with over 5000 patient forms submitted to the NB in 2022 alone.
Ensure your medical devices meet EUMDR standards with our tailored PMCF surveys. Gain valuable post-market insights and maintain compliance with our expert support. At Cetas Healthcare, we simplify regulatory processes, offering precise data collection and analysis to keep your products safe and compliant. Trust us to navigate the complexities of EUMDR with ease.
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.
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,
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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