Matrix One>West coast forum>Regulatory Breakfast — San Francisco

Regulatory Breakfast

San Francisco, CA · Wed 19 Aug · 7:30–9:00 AM · With Goodwin

A closed-door breakfast roundtable for Bay Area RAQA professionals, hosted at Goodwin's San Francisco office. An ex-FDA speaker leads the discussion on how AI is accelerating 510(k) and PMA submissions, strengthening design history file traceability, and changing audit readiness for quality teams. Seats are capped to keep the conversation focused.

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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 being used to draft, review, and accelerate 510(k) and PMA submissions.

Design Control & DHF Documentation

Design Control & DHF Documentation

Using AI to maintain design history files, trace requirements, and keep your DHF audit-ready.

Quality Management & Audit Readiness

Quality Management & Audit Readiness

How AI-powered QMS platforms are changing the way MedTech companies handle CAPAs, nonconformances, and supplier quality.