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Matrix One>West coast forum>Cloud Connected MedTech Dinner: Risk and Regulation, Irvine

Cloud Connected MedTech Dinner: Risk and Regulation
Irvine, CA · Tue 25 Aug · 5:30 to 8:00 PM

A dinner for engineers and CTOs building cloud connected medical devices, held at Warehouse 72 in Irvine. Over dinner we get into the risk and regulation that come with connected products: cloud architecture that clears security review, data residency, HIPAA, audit trails, and FDA cybersecurity guidance. Then we show how Matrix One handles design control and quality documentation for connected devices.

📍 Location: Warehouse 72, 17900 Jamboree Rd, Irvine, CA 92614

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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.

Cloud Architecture for Regulated Devices

Designing cloud infrastructure for regulated devices: data residency, HIPAA alignment, audit trails, and FDA clearance decisions.

Security & SaMD Compliance

Navigating FDA's cybersecurity guidance and the SaMD framework while keeping engineering velocity high.

Connectivity in Practice

How connected MedTech products handle data flow, interoperability, and scale in production.