Post-Market Clinical Follow-Up Survey Platform
Streamline your PMCF data collection with our compliant, scientifically validated platform. Designed for medical device companies to meet MDR requirements efficiently.
What are PMCF Surveys?
PMCF surveys or 'end user' surveys are a valid method of collecting post-market clinical data. They provide critical insights into device performance and user experience from both healthcare professionals and patients.
General Surveys
Retrospective design for lower-risk devices and established technologies. Collect broad user feedback and satisfaction data efficiently.
Specific Surveys
Patient-level case studies for high-risk devices. Prospective design with series of surveys tracking device usage and patient outcomes over time.
Important: These are not marketing surveys. PMCF surveys are clinical data generation tools designed to fill data gaps and support ongoing clinical evaluation under MDR requirements.
Data Capture Platform Engineered for Medical Device PMCF Surveys
Collect scientifically valid and MDR compliant PMCF data using our state-of-the-art platform
Pre-validated & Compliant
Our platform meets ISO14155:2020 requirements and GDPR standards. Built with regulatory compliance at its core.
Fully Documented Traceability
All data inputs include automatic user identification ensuring complete traceability from source to sponsor using state-of-the-art technology.
Easy GDPR Compliance
Seamlessly comply with GDPR requirements for informed consent and data protection. Our in-house data protection officer monitors all studies.
When are surveys a good choice?
Surveys are ideal when you have direct access to end-users and need an agile, resource-efficient tool that can reach different user groups without group size limitations. They’re particularly effective in remote settings, reducing the need for research personnel and minimizing patient burden.
Frequently Asked Questions
Common questions about PMCF surveys and our platform
The cost varies depending on the scope of research, sample size, and complexity of your study. We recommend evaluating costs against potential benefits and regulatory requirements. Contact us for a customized quote tailored to your specific needs
Typically, it takes 4-6 weeks to collect survey responses and another 2-4 weeks to analyze the data. However, timelines can be expedited or extended based on your project’s specific requirements and complexity.
Absolutely. We take confidentiality very seriously and use secure systems and processes to ensure all survey responses are kept confidential. Results are only shared with authorized individuals within your organization and third-party partners who have signed non-disclosure agreements.
PMCF surveys can collect a wide range of clinical and user experience data including demographic information, device usage patterns, adverse events, patient outcomes, clinical effectiveness data, and user satisfaction metrics – all critical for fulfilling MDR post-market surveillance requirements.
Yes, our platform offers extensive customization options to ensure survey questions and format align with your specific needs and research objectives. We work closely with you to develop surveys tailored to your target audience, device type, and regulatory requirements.
