Launching a new wound care device is never simple. For one leading manufacturer preparing to introduce its latest Negative Pressure Wound Therapy (NPWT) system, success hinged on one thing: Level 8 Post-Market Clinical Follow-up (PMCF) data. They needed robust, real-world evidence, proof of how the product performed in everyday clinical practice.
The challenge? Capturing consistent, compliant data not just across Europe, but also North America and Asia.
That’s where we came in.
Nine countries, all with different healthcare systems, cultures, and regulatory expectations.
Busy healthcare professionals (HCPs).
A tight regulatory timeline with no room for delays.
Our task was to design and deliver a PMCF program that worked seamlessly across markets, meeting MDR standards, engaging clinicians, and producing data the manufacturer could trust.
Our Approach
We built a survey program that was:
Concise: a 20-minute online questionnaire, focused on real-world use, safety, and usability.
Localized: translated and culturally adapted for each market.
Targeted: only HCPs with direct experience of the NPWT system were invited.
Compliant: GDPR-aligned, anonymised, and structured to meet MDR Level 8 PMCF standards.
We reached wound care specialists, nurses, and physicians across all nine countries.
Completion on time and in scope, hitting MDR deadlines without compromise.
Engagement of clinicians across diverse markets.
A compliant, high-quality dataset ready for integration into the client’s MDR submission.
This project demonstrated that PMCF can be global, efficient, and clinician-friendly. For the manufacturer, it meant regulatory progress and market confidence. For HCPs, it was a quick, relevant way to contribute to product evaluation.
Keep it simple to respect clinicians’ time.
Adapt surveys to each local market for clarity and engagement.
Build strong local partnerships to accelerate recruitment.
A consistent central framework ensures global success.
By delivering a complex, multi-country PMCF program across nine countries, we enabled our client to collect the post-market evidence needed for their EU MDR submission, on time, at scale, and with full regulatory compliance.