How Meta Achieved Its First 510(k) While Maintaining Its Best-in-Class Engineering Velocity and Culture

When Meta’s Reality Labs set out to achieve its first 510(k) approval for its hearing-enabled smart glasses to market, the goal was clear: preserve its world-class engineering velocity and culture while applying medical-grade rigor to the software components classified as medical devices. Balancing rapid iteration with regulatory rigor required changes to collaboration, tooling, and quality management from development through 510(k) submission. In this session, Liz Khalil, Regulatory Affairs Lead, Health Technology at Meta and others from the Meta team will walk through how Meta aligned development practices with FDA and IEC 62304 requirements without slowing teams down. You’ll learn how Meta: