- Conference
MedTech Innovation & Validation University
Integrating Compliance, Design, and Post Market Success
- Philadelphia, PA
- October 7-8
- Prices increase September 4!
Attend Virtually or In-Person
Top 10 Challenges MEDTECH VALIDATION & INNOVATION LEADERS are solving IN 2026
Gold Sponsors
Overview
The regulatory landscape has shifted – and MedTech Validation & Innovation University 2026 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
Faculty
Please Note: KENX does not issue refunds. If you are unable to attend after registering, we are happy to apply your registration fee toward a future KENX event or transfer your registration to a colleague. All cancellation or transfer requests must be received at least seven days prior to the event.