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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 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.
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 the design, conduct, recording, and reporting of clinical investigations involving medical devices. Recognizing that each medical equipment portfolio has unique requirements, we customize our approaches to meet your specific needs, ensuring that our solutions align perfectly with your objectives.
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.
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.
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
We provide the best insights for your business