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Cetas Healthcare specializes in Post-Market Clinical Follow-up (PMCF) Surveys designed to ensure the ongoing safety, performance, and effectiveness of medical devices and medical equipment. Our tailored solutions align with the rigorous requirements of EU MDR, ISO 14155, and other global regulatory standards. These videos teach 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.
Meeting IVDR and EU MDR Compliance
For manufacturers of in vitro diagnostic (IVD) devices, compliance with the In Vitro Diagnostic Regulation (IVDR) is critical. Our PMCF strategies bridge the gap between regulatory expectations and real-world data collection. Whether you’re preparing for audits or enhancing device approval prospects, we provide data-driven insights for both IVDR and EU MDR adherence.
ISO 14155-Compliant Clinical Research
We follow ISO 14155 guidelines to conduct robust PMCF studies that adhere to the highest standards of clinical investigation. This ensures your data is credible, reproducible, and aligned with international best practices, helping your medical equipment gain trust and long-term market success.
The MDR requires manufacturers to conduct PMCF activities proportionate to the device’s risk. For low-risk devices, surveys may be the only required PMCF activity. For higher-risk devices, surveys may be used in combination with other PMCF activities, such as clinical studies.
At Cetas Healthcare, we conduct comprehensive surveys for medical devices and in vitro diagnostics (IVDs), ensuring compliance with both the In Vitro Diagnostic Regulation (IVDR) and the European Union Medical Device Regulation (EU MDR). Our team adheres strictly to ISO 14155 standards, which provide guidelines for designing, conducting, recording, and reporting clinical investigations involving medical devices. Recognizing that each medical equipment portfolio has unique requirements, we customize our approaches to meet your needs, ensuring that our solutions align perfectly with your objectives.
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 help you navigate the complexities of EUMDR with ease.
At our core, we're driven to help medical device manufacturers access cost-effective means of gathering substantial real-world evidence via PMCF surveys.
Our PMCF solutions empower your team to navigate the complexities of regulatory landscapes while ensuring optimal device performance and patient safety.
For more information, visit our Clinical and Regulatory Services page.
A PMCF (Post-Market Clinical Follow-up) Survey is a targeted research method used to gather real-world evidence about the safety, performance, and effectiveness of medical devices after they have been introduced to the market. It helps manufacturers comply with
EU MDR and IVDR regulations by systematically collecting data from patients, healthcare professionals, and other stakeholders.
PMCF Surveys enable MedTech manufacturers to bridge the gap between regulatory requirements and real-world data collection. They provide data-driven insights on device safety, performance, and patient outcomes, ensuring ongoing compliance with EU MDR and IVDR guidelines, especially for legacy devices or high-risk equipment.
Cetas Healthcare follows ISO 14155 standards to design and conduct robust PMCF Surveys. The process includes designing MDCG-7 compliant survey plans, creating MDCG-8 aligned user survey reports, and integrating findings with Clinical Evaluation Reports
(CER). Additionally, our panel of healthcare professionals (HCPs) provides access to targeted respondents for reliable data collection.
For legacy medical devices that have been in the market for a long time, PMCF Surveys provide a proactive approach to collecting updated real-world data. By engaging patients and HCPs through questionnaires and observational studies, Cetas Healthcare helps
manufacturers validate device performance and address potential safety issues, ensuring continued regulatory approval.
We implement ISO 14155-compliant methodologies, including rigorous data collection protocols, patient confidentiality safeguards, and structured reporting formats. Our survey designs are tailored to meet EU MDR and IVDR requirements, ensuring the credibility and
reproducibility of all collected data.
Yes, for low-risk devices, PMCF Surveys may be the only required activity under EU MDR. Higher-risk devices can be used in conjunction with other PMCF activities, such as clinical investigations or registry studies.
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