The MDSAP certificate program is overseen by the International Medical Device Regulators Forum, a global audit program that leverages regulatory resources to manage an efficient, effective, and sustainable single audit program, Lunit said. Manufacturers are certified for a single quality management system audit in place of multiple audits by regulatory agencies for five countries, including the U.S., Canada, Japan, Australia, and Brazil.
The certification is considered evidence of a medical device manufacturer's commitment to product quality and regulatory compliance, Lunit said.
Lunit's plans to officially launch its Insight DBT and Lunit Insight Chest CT products this year after highlighting them at RSNA 2021.
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