Lunit Obtains MDSAP Certificate, Granted Fast-Track Regulatory Process In Major Countries

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By PR Newswire Lunit meets MDSAP requirements as a global standard medical AI software manufacturerQMS audit exemption in the US, Canada, Japan, Australia, and BrazilSEOUL, South Korea, Dec. 27, 2021 /PRNewswire/ — Lunit, a leading AI software company for cancer screening and treatment, announced it has obtained MDSAP (Medical Device Single Audit Program) certificate. The MDSAP, operated by International Medical Device Regulators Forum (IMDRF), is a global audit program that leverages regulatory resources to manage an efficient, effective and sustainable single audit program. A certified manu…

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