Post-Market Surveillance Best Practices for Advanced Wound Care Devices: Expert Insights
Post-Market Surveillance Best Practices for Advanced Wound Care Devices: Expert Insights By Denis Katz, MD — Founder & Principal, Katz Medical Affairs Consulting | Specialist in Medical Device Compliance & Post-Market Surveillance In today’s MedTech landscape, post-market surveillance (PMS) has evolved from a regulatory checkbox to a strategic driver of patient safety, clinical evidence, and market success. Advanced wound care devices, given their complex patient populations and diverse surgical applications , demand tailored PMS approaches that address unique clinical and regulatory challenges. Drawing on extensive experience in medical affairs and compliance, this analysis outlines practical strategies for effective PMS implementation, illustrated through the case study of Solventum’s Prevena Restor Incision Management System the first negative pressure wound therapy device to receive FDA clearance to aid in reducing superficial surgical site infections in certain ...