Laboratory University

Mastering Analytical Methods, Stability Testing, and QC Excellence

Attend Vitually or In-Person

Gold Sponsors

Overview

The regulatory landscape has shifted – and MedTech Validation & Innovation University 2025 is your opportunity to build a forward-looking validation program that’s compliant, flexible, and audit-ready. From FDA’s QMSR overhaul to AI/ML final guidance, cybersecurity enforcement, and LDT oversight rollout, regulatory expectations are no longer evolving — they’re here. This program delivers real-world strategies, case studies, and hands-on tools to help you implement what matters most – now.

What You’ll Learn

Apply Computer Software Assurance (CSA) across systems, software, and documentation
Implement controls aligned with QMSR and ISO 13485 ahead of 2026 enforcement
Validate AI and adaptive software under the FDA’s final AI/ML guidance
Build audit-ready documentation for cybersecurity, cloud platforms, and SBOMs
Prepare for EU MDR/IVDR transitions and notified body expectations
Translate real-world evidence (RWE) into regulatory submissions
Comply with new LDT regulation beginning May 2025
Connect design control, usability, and risk for stronger submissions
Leverage supplier oversight dashboards and remote audit strategies
Align your Part 11 compliance for modern, cloud-based environments

Special Features

34 sessions across CSA, QMSR, AI, Postmarket, and Global Regulatory
Action-driven titles and case studies — no theory-heavy fluff
New LDT session focused on complaint handling and labeling requirements
Cybersecurity tracks and panels tied to real audit trends and SBOM guidance
Hands-on workshops for CSA validation and EU MDR/IVDR strategy
Sessions addressing global authorities: Health Canada, TGA, ANVISA, and EU NB expectations
Expert-led panels and Q&A sessions featuring industry and regulatory specialists