Overview
The regulatory landscape has shifted – and Medical Device Validation 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

Who Should Attend

• Validation, QA, and CSV/CSA Professionals
• Regulatory Affairs and Global Compliance Teams
• Design, Risk Management, and R&D Engineers
• Cybersecurity, Cloud, and IT Compliance Leads
• Supplier Quality, Auditing, and Postmarket Leaders