Medtech Fireside: The Recall, The RTA, and the Successful 510(k)
About the Event
🌟 If you're in medtech, this is the fireside you don't want to miss!
An RTA letter can kill your submission before it is even reviewed, and a recall can jeopardize an entire product line. Everyone aims for a clean 510(k), yet few agree on how to achieve it. This event convenes directors, VPs, and executives from Product Security, Quality, and Regulatory in the same room for honest discussions.
➡️ Structured talks by each discipline will lead to a unique fireside conversation: no slides, no talking points—just real dialogue about what happens when a submission goes sideways or a device is pulled from the market.
Featured Speakers
Experts from MedTech Top 100 companies across Regulatory, Product Security, and Quality sectors will be present. The speaker roster will be finalized soon, with updates shared in the MDSI Slack.
Key Topics Covered
- What triggers a Refuse-to-Accept and how to prevent it
- The regulatory pathway from a security team's perspective, beyond QA/RA
- Practical changes following post-524B regulations
- Implications of AI-enabled devices in submission pipelines, including RTA risks and threat models
- Collaboration opportunities between Product Security, Quality, and Regulatory—and points of failure
- Insights from real recall postmortems not shared in public reports
Why Attend
- Network with Director, VP, and executive-level peers across Product Security, Quality, and Regulatory
- Gain insights and discussions unique to this setting that aren't found elsewhere
- Depart with practical strategies that truly work, rather than what's just meant to work
Agenda
- 8:30 - 9:00 | Doors Open, Coffee & Networking ☕
- 9:00 - 12:30 | Program: Speaker Talks & Fireside Conversation 🗣️
- 12:30 - 1:00 | Networking Close 🤝
This is the inaugural MDSI Forum—applications will close as seats fill up. If you're in medtech, be there!
📍 Location: Stellartech Research Corporation, 560 Cottonwood Dr, Milpitas, CA 95035, USA
Stellartech Research Corporation, 560 Cottonwood Dr, Milpitas, CA 95035, USA
RouteMit der Kamera scannen – die Veranstaltung öffnet sich in der Somo-App.
