Reliable clinical evidence collected methodically and in compliance with European Regulation.
Under Regulation (EU) 2017/745 (MDR), post-market data collection is essential to ensure the safety and performance of medical devices throughout their entire lifecycle.
High-Quality PMCF surveys are a strategic tool for generating real-world clinical evidence, especially when:
- The medical device has gaps in clinical data
- Specific claims need to be supported
In such cases, surveys are a valuable method for collecting meaningful information to demonstrate compliance with applicable GSPRs, complementing other PMCF activities tailored to the device.
Clariscience has developed a comprehensive service for the design and implementation of High-Quality PMCF surveys, in accordance with Appendix III of MDCG 2020-6 and aligned with MDR principles.
A rigorous and sustainable approach, designed to transform data collection into a concrete clinical and regulatory advantage.
A complementary and value-driven activity designed to accelerate data collection, strengthen the manufacturer’s regulatory strategy and support clinical investigations by integrating necessary evidence
A practical tool to support the manufacturer throughout the device life cycle
Our 4-step method:
1.Clinical-regulatory context analysis
We review existing documentation to identify clinical gaps and define clear objectives aligned with the device’s claims and clinical benefits in order to develop targeted survey questions.
2.Protocol design
We draft a streamlined yet robust protocol, that ensures consistency, traceability, and methodological rigor.
3.Statistical analysis plan
We develop a solid statistical plan to identify relevant metrics, optimize the survey structure, define the number of questions, and determine the appropriate sample size to ensure data validity and quality.
4.Questionnaire development
Based on thorough literature research and the survey’s objectives, we design targeted questions to collect specific data aligned with the device’s regulatory context.
When is a High-Quality PMCF survey useful?
- To address gaps in existing clinical data
- As a complement to an ongoing clinical investigation
- To collect evidence quickly and sustainably
- To demonstrate proactive data collection throughout the device lifecycle
Every device is unique. So is our strategy: we evaluate each project individually to define the most suitable clinical-regulatory strategy.
Wondering if a High-Quality PMCF survey is the right tool for your device?
Contact us for a free preliminary assessment.
With Clariscience, data collection creates evidence. And evidence, value.
