Beyond the Red Tape: Scaling Connected Health in 2026

As healthcare moves toward proactive, preventive, and AI-enabled care models, the regulatory boundary between “wellness” and “medical device” has been fundamentally redefined. This event brings together leading experts in Regulatory Affairs, Quality, Connected Health, and Digital Health to discuss how organizations can successfully scale connected ecosystems in this new regulatory era.

Key topics include:
💡 The 2026 FDA regulatory changes impacting Connected Health and Clinical Decision Support (CDS)
💡 How companies are navigating the evolving “wellness vs. medical device” boundary
💡 AI-enabled sensors, remote monitoring, and digital health ecosystems
💡 Using Predetermined Change Control Plans (PCCPs) for AI and software lifecycle management
💡 Strategies to accelerate innovation while maintaining compliance
💡 Data validation and regulatory considerations for next-generation connected platforms

🎤 Featured Speakers:
Ritam Priya — Principal, Novarum MDRQ Consulting
Walt Cecka — Medical Technology Fellow, Triple Ring
Yusi Liu, RAC., SVP of RA and QA, BioIntelliSense Inc.
Jeanne Zhang, Principal Regulatory Affairs Specialist, MiniMed
Aarti Shukla, M.S.Rsc, RAC, Regulatory Affairs, Roche

🤝 The evening will also include networking opportunities and an exclusive facility tour of Triple Ring Technologies.

Whether you work in Regulatory Affairs, Quality, Digital Health, MedTech, AI, Software, or Connected Devices, this is a conversation you won’t want to miss.

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