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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.
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