Lunit nabs joint regulatory certification

By staff writers

January 4, 2022 -- Artificial intelligence (AI) software developer Lunit has received the Medical Device Single Audit Program (MDSAP) certificate after meeting requirements as a global standard medical AI software manufacturer.

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.

Copyright © 2022

To read this and get access to all of the exclusive content on create a free account or sign-in now.

Member Sign In:
MemberID or Email Address:  
Do you have a password?
No, I want a free membership.
Yes, I have a password:  
Forgot your password?
Sign in using your social networking account:
Sign in using your social networking