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Regulatory

📄️ Medical Device Certification

Regulatory pathway

📄️ Quality Management System

Legit.Health operates a fully certified Quality Management System (QMS) for the design, development and commercialization of software as a medical device. The product is a Class I medical device CE-marked under MDD (2020), in transition to Class IIb under EU MDR (Rule 11) with notified body BSI.

📄️ FDA Strategy

Series A catalyst

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Medical Device Certification
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