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Maximizing Safety and Integrity in Orthopedic Clinical Trials with RBQM: A Strategic Approach by Denis Katz, MD

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Maximizing Safety and Integrity in Orthopedic Clinical Trials with RBQM: A Strategic Approach by Denis Katz, MD Introduction Orthopedic clinical trials  characterized by complex surgical interventions, device-specific variables, and extended rehabilitation follow-ups are prime candidates for  Risk-Based Quality Management  (RBQM) . RBQM is an adaptive, data-driven quality framework that focuses oversight on what is most critical to participant safety and the validity of trial conclusions. In January 2025, ICH finalized the  E6(R3)  update to Good Clinical Practice, which explicitly embeds RBQM principles and encourages sponsors to integrate critical-to-quality thinking across the clinical development lifecycle. Understanding Risk-Based Quality Management RBQM is now the prevailing approach to clinical trial oversight in regulated drug, biologic, and device development. The core idea is  proportionality : monitoring intensity and quality controls are aligned...
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Maximizing Safety and Integrity in Orthopedic Clinical Trials with RBQM: A Strategic Approach by Denis Katz, MD

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Maximizing Safety and Integrity in Orthopedic Clinical Trials  with RBQM: A Strategic Approach by Denis Katz, MD Introduction Orthopedic clinical trials  characterized by complex surgical interventions, device-specific variables, and extended rehabilitation follow-ups are prime candidates for Risk-Based Quality Management (RBQM) . RBQM is an adaptive, data-driven quality framework that focuses oversight on what is most critical to participant safety and the validity of trial conclusions. In January 2025, ICH finalized the E6(R3)  update to Good Clinical Practice, which explicitly embeds RBQM principles and encourages sponsors to integrate critical-to-quality thinking across the clinical development lifecycle. Understanding Risk-Based Quality Management RBQM is now the prevailing approach to clinical trial oversight in regulated drug, biologic, and device development. The core idea is proportionality : monitoring intensity and quality controls are aligned to the risks tha...
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Post-Market Surveillance Best Practices for Advanced Wound Care Devices: Expert Insights

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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 ...
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