Denis Katz clinical consultant


Deniskatz1095

Uploaded on Jan 20, 2026

Medical-device development is unlike typical software or manufacturing environments because products directly impact patient safety and must satisfy stringent regulatory expectations across the entire product lifecycle. The U.S. FDA’s Quality Management System Regulation (QMSR), which becomes enforceable February 2, 2026, replaces the former Quality System Regulation (QSR) and aligns 21 CFR Part 820 with ISO 13485:2016 principles. This harmonization elevates global consistency while preserving core quality expectations.

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Denis Katz clinical consultant

Strategic Medical Aairs and Regulatory Expertise for Pharma, Biotech, and MedTech. Salience Clinical is a boutiue consultancy specializing in CNS and Biologics...” Value Highlights: Deep expertise, senior-level engagement, agility, global perspective. WORK WITH US LEARN MORE ABOUT OUR EXPERTISE We respect your privacy SERVICES Cookies help us improve your experience, deliver personalized content, and analyze trac. You can choose which cookies to allow by clicking Customize. Click Accept All to consent or Reject All to decline non-essential cookies. Customize Reject All Accept All Powered by Medical Aairs Strategy Launch Readiness RWE Strategy Regulatory Support TESTIMONIALS On Regulatory Execution During our most complex health authority interactions, Salience Clinical became our strategic anchor. As our principal clinical strategist, they authored core sections of our regulatory submissions and served as our primary interface with FDA and EMA. eir ability to cut through ambiguity and isolate what truly matters for approval is rare. Global Pharmaceutical Company Head of Regulatory Aairs DISCLAIMER Testimonials reect the experiences of senior leaders at sponsor organizations. Identifying details have been anonymized to protect condentiality. Results may vary depending on program scope, development stage, and regulatory context. LET’S BUILD WHAT’S NEXT! Empowering ideas, inspiring innovation, and creating future-ready solutions that move your vision forward—one bold step at a time. SCHEDULE A CONSULTATION Home About Services erapeutic Expertise Leadership Experience & Case Insights Contact  Copyright by © Salience Clinical, LLC