​About Event

​Silicon Valley, August. If you're in medtech, this is the fireside you don't skip.

​An RTA letter kills your submission before anyone reviews it. A recall can kill the product line. A clean 510(k) is the outcome everyone wants and nobody agrees on how to get. The people who actually own that outcome, at the Director, VP, and executive level, across Product Security, Quality, and Regulatory, have never been in the same room talking about it honestly.

​This is that room, and it's the first one. Structured talks from each discipline, then the three converge for a fireside: no slides, no talking points, just what actually happens behind the scenes when a submission goes sideways or a device gets pulled.

​Featured Speakers

​Speakers are being recruited from MedTech Top 100 companies, across Regulatory, Product Security, and Quality. Roster locks soon, updates land in the MDSI Slack.

​Key Topics Covered

• ​What actually triggers a Refuse-to-Accept, and how to avoid one

• ​The regulatory pathway from a security team's perspective, not just a QA/RA one

• ​What changes post-524B, in practice, not in theory

• ​AI-enabled devices are already in submission pipelines, what that does to your RTA risk and your threat model

• ​How Product Security, Quality, and Regulatory should actually work together, and where that breaks down

• ​Real recall postmortems, what nobody puts in the public writeup

​Why Attend

• ​Director, VP, and executive-level peers across Product Security, Quality, and Regulatory, in one room

• ​What gets said here doesn't get said in public anywhere else.

• ​Walk out with what actually works, not what's supposed 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

​The first MDSI Forum. Applications close as the room fills. If you're in medtech, be here.