Matrix One>West coast forum>Regulatory Breakfast — Redwood City

Regulatory Breakfast

Redwood City, CA · Thu 20 Aug · 7:45 to 9:30 AM

A closed-door breakfast for Peninsula-area RAQA professionals, hosted at Goodwin's Redwood City office. An ex-FDA speaker joins the discussion on how AI is accelerating 510(k) and PMA preparation and helping teams keep their design history files audit-ready. This roundtable is capped at a small number of attendees to preserve the quality of discussion.

📍 Location: Goodwin, 601 Marshall St, Redwood City, CA 94063

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Agenda

Roundtable breakfast · 7:45 to 9:30 AM

7:45 to 8:15 AM
Arrivals and open networking
Coffee, breakfast, and time to connect with peers before we begin.
8:15 to 8:20 AM
Welcome and introductions
A quick round of who is in the room.
8:20 to 9:15 AM
Roundtable discussion
A guided, closed door conversation on how AI is transforming regulatory work. We get into:
•Where AI saves time in 510(k) and PMA prep, and where it is risky
•Keeping design history files audit ready with AI in the loop
•What reviewers look for in AI assisted submissions
•Choosing an LLM for regulatory work, and data security
•How other MedTech teams are using AI today, and where they keep a human in the loop
9:15 to 9:30 AM
Takeaways and wrap
Key takeaways, plus the practical AI checklist to take home.

Guest Speakers at our West Coast MedTech Forum events

Louis Albert

Louis Albert

CEO, Matrix One

Chief Executive of Matrix One, the MedTech platform for regulatory, quality and product teams.

Neha Elena Sam

Neha Elena Sam

Business Development Engineer

Helping medical device and life sciences teams implement design control and eQMS software to bridge agile development with regulatory compliance.

Alex Condon

Alex Condon

COO, Matrix Connect (Matrix One)

Co-founded Galen Data in 2016, later acquired and rebranded as Matrix Connect. Previously Chief Strategy Officer at Tietronix Software.

AI in Regulatory Submissions

AI in Regulatory Submissions

How AI tools are accelerating 510(k) and PMA preparation.

Design Control & DHF Documentation

Design Control & DHF Documentation

Using AI to maintain traceability across design history files and keep your DHF audit-ready.

Quality Management & Audit Readiness

Quality Management & Audit Readiness

How AI-powered QMS platforms are changing Peninsula MedTech companies.