How to Address Clinical Data Gaps Through Post-Market Clinical Follow-up Surveys
Clinical evaluation requires medical device manufacturers to assess if their clinical data/evidence is sufficient to support the device’s intended use, stated lifetime, and performance claims. If clinical gaps are identified, more clinical data/evidence must be collected to close these gaps.
Post-Market Clinical Follow-up (PMCF) surveys can help address clinical data gaps that may impact the ongoing assessment of a medical device’s safety and performance. Unearthing clinical gaps requires a systematic approach, including a review of clinical literature, post-market surveillance data, and regulatory compliance standards.
Download this complimentary infographic to discover essential tips for addressing clinical gaps with PMCF Surveys:
Key considerations
When to use PMCF Surveys
Designing PMCF Surveys
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Purdie Pascoe PMCF survey expertise
Purdie Pascoe has developed a best-practice approach, approved by EU regulators and compliant with ISO requirements and GDPR regulations, for PMCF surveys. We can support you with the design, implementation, data collection and reporting of your PMCF surveys to ensure you collect appropriate PMCF data to be used within your MDR submissions.