A leading wound care manufacturer was preparing to launch a new Negative Pressure Wound Therapy (NPWT) system into global markets. Regulatory success depended on one critical factor: Level 8 Post-Market Clinical Follow-up (PMCF) data under EU MDR.
They needed robust, real-world evidence showing how the system performed in everyday clinical use — not just in one region, but across Europe, North America, and Asia.
The challenge was significant:
Nine countries with different healthcare systems and regulatory environments
Time-poor clinicians
A fixed MDR timeline with no room for slippage
Failure to deliver consistent, compliant data across all markets would put both regulatory approval and commercial launch at risk.
1. Regulatory-Aligned Study Design
We designed a PMCF programme built specifically to meet MDR Level 8 requirements, ensuring that all data collected would be usable in the client’s regulatory submission.
The framework was aligned to:
Real-world clinical use
Safety and usability outcomes
GDPR and data-privacy requirements
2. Global, Localised Execution
We developed a concise, 20-minute online survey optimised for busy wound care clinicians and deployed it across nine countries.
The programme was:
Localised – translated and culturally adapted for each market
Targeted – restricted to HCPs with direct experience of the NPWT system
Compliant – fully anonymised, GDPR-aligned, and audit-ready
Wound care nurses, physicians, and specialist clinicians were recruited through established local networks to ensure speed and data quality.
3. Central Control, Local Delivery
A single, centrally governed framework ensured consistency across countries, while local field teams handled recruitment and language adaptation — allowing the study to move quickly without sacrificing regulatory rigour.
The project delivered:
A multi-country MDR-compliant PMCF dataset
Real-world evidence on use, safety, and usability
Consistent, structured data across nine markets
Documentation ready for direct integration into the client’s MDR submission
This project enabled the client to meet a critical regulatory milestone without compromising on data quality or timelines.
By combining global coordination with local execution, we helped the manufacturer:
Complete PMCF on time and in scope
Engage clinicians across multiple healthcare systems
Secure a high-quality evidence base to support their MDR filing
De-risk the commercial launch of their new NPWT system
The result was regulatory progress, commercial confidence, and a clear pathway to market — proving that even complex, multi-country PMCF programmes can be delivered efficiently, at scale, and with full compliance.