The regulatory landscape for connected medical technology reached a critical pivot point in January 2026. As healthcare shifts from a reactive model toward proactive, preventive care, the "Red Tape" governing digital health has been significantly rewritten. These reforms have expanded enforcement discretion for a wide array of connected technologies—from high-fidelity clinical sensors to AI-driven decision support—allowing for faster innovation and market entry.
This session brings together a panel of industry leaders to dissect the practicalities of scaling Connected Health & Digital ecosystems. We will move beyond hardware specifics to discuss the regulatory architecture required to navigate this new era.
Key Discussion Pillars:
- The 2026 Regulatory Pivot: A deep dive into the practical application of the latest FDA cuts to General Wellness and Clinical Decision Support (CDS) guidances.
- The Data-to-Clinical Bridge: Strategies for evolving products from low-risk data collection to high-fidelity clinical diagnostics as intended use and risk levels increase.
- AI & Sensor Integration: Utilizing Predetermined Change Control Plans (PCCPs) to manage the lifecycle of software-driven connected devices without constant re-submissions.
- Building the "Clear Lane": How RA/QA leaders can interpret the "wellness vs. medical" boundary to build a proactive, compliant roadmap for complex digital health platforms.
Learning Objectives
By attending this event, participants will be able to:
- Analyze the 2026 updates to FDA General Wellness and CDS guidance and their impact on a broad range of connected product classifications.
- Distinguish between wellness and medical-grade claims within complex digital ecosystems to mitigate enforcement risks.
- Develop a regulatory lifecycle strategy that leverages the latest exemptions and PCCP frameworks to accelerate the time-to-market for software-driven technology.
- Evaluate the data validation requirements necessary to satisfy both clinical efficacy and regulatory "low-risk" criteria in a post-reform market.
Agenda
5:00 PM – 5:30 PM: Registration & Networking
5:30 PM – 5:45 PM: RAPS SF Chapter Welcome & Introduction
5:45 PM – 6:00 PM: Host Introduction: Triple Ring Technologies
6:00 PM – 7:00 PM: Panel Discussion: Scaling Connected Health in the 2026 Regulatory Landscape
7:00 PM – 8:00 PM: Networking & Refreshments
Location
Triple Ring Technologies (TRT)
39655 Eureka Drive
Newark, CA 94560
Cancellations and Refunds
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to [email protected]. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email [email protected] with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected].
Speakers
