Post Market Surveys
A global imperative
The global regulatory environment for medical devices is rapidly evolving, with increased emphasis on Post-Market Surveillance (PMS) requirements, particularly under the EU MDR/IVDR and FDA frameworks. At the core of this shift is the need for ongoing, high-quality clinical evidence to demonstrate the real-world safety and performance of devices.
Post Market Surveys, including PMCF (Post-Market Clinical Follow-up) and PMPF (Post-Market Performance Follow-up), offer an efficient, scalable way to collect Real-World Data (RWD) and generate Real-World Evidence (RWE), key to regulatory compliance, global submissions, and market success.
Why do Post Market Surveys matter?
Post Market Surveys enable manufacturers to proactively collect real-world data outside of traditional clinical trials, collecting safety and performance data from device use across diverse populations and settings. This evidence is critical to:
Demonstrate ongoing safety and performance
Meet EU-MDR and IVDR requirements
Support FDA and wider global submissions
Enable label and indication expansions
Enhance global market access
Compared to clinical investigations and registries, which can be costly and time-consuming, Post Market Surveys are cost-effective, scalable and quicker to deploy, while still providing robust, high-quality data.
With over 400 surveys delivered in the past five years, Purdie Pascoe is a trusted leader in Post Market Survey execution
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Specialist team
Dedicated post market experts delivering best-in-class, compliant and regulator ready solutions
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400+ PMCF surveys completed
High-quality case specific surveys (Level 4)
General end-user surveys (Level 8) -
Device expertise
In-depth experience across a wide range of device types and risk classifications
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Quality and compliance
Robust compliance and quality assurance protocols in accordance with ISO 9001, Quality Management System and ISO 14155
Our expertise spans three key areas
From EU-MDR, IVDR, to wider global requirements, we can help you generate the evidence that supports compliance and drives value
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PMCF Surveys for EU-MDR compliance
Real-world clinical data to demonstrate ongoing safety and performance of medical devices in the EU
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PMPF Surveys for EU-IVDR compliance
Post-market performance data for IVDs to meet IVDR requirements and support continuous evaluation
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Global Post Market Surveys & Real-World Evidence
Surveys designed to support broader regulatory and commercial goals, including: Global submissions (e.g. FDA & NMPA) and indication / label expansion
We support you across the full lifecycle of your survey:
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Design & Planning
Objectives/endpoint & survey development
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Programming
Custom surveys built within a validated platform
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Data Collection
HCP and patient recruitment & engagement
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Analysis & Reporting
Statistical analysis & medial writing
Our Post Market Survey Process
Proactively assessing the safety and performance of your medical device continuously throughout the product’s lifecycle
The Outcomes:
Confirm safety and performance
Identify unknown side-effects
Identify and analyse emergent risks
Ensure the continued acceptability of the benefit-risk ratio
Identify possible systematic misuse or off-label use
Recent Insights:
Want to partner with us for your next Post Market Survey?
Get in touch.
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Purdie Pascoe: Your Partners in Post Market Surveys
