- Lunit meets MDSAP requirements as a global standard medical AI software 
manufacturer 
- QMS audit exemption in the US, Canada, Japan, Australia, and Brazil


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 manufacturer is allowed for a single quality management system 
audit in place of multiple audits for five countries, including the United 
States (FDA), Canada (Health Canada), Japan (MHLW), Australia (TGA), and Brazil 
(ANVISA). The certification is considered evidence of a medical device 
manufacturer's commitment to product quality and regulatory compliance.

In 2021, FDA said it would accept MDSAP audit reports as a "substitute" for 
routine agency inspections. In 2019, the Canadian government strengthened 
market requirements to allow only those who acquired MDSAP certificates.

According to the Korea Health Industry Development Institute, the medical 
device market size in the above five countries is estimated at USD 223.2 
billion, which makes up about 55 percent of the global medical device market.

"MDSAP certificate signals global recognition for an excellent quality 
management of our products," said Brandon Suh, CEO of Lunit. "We are looking 
forward to speeding up global market expansion with our AI solutions both 
currently commercialized and in the pipeline."

Lunit INSIGHT CXR for chest X-ray images and Lunit INSIGHT MMG for mammography 
are already used at 450 medical institutions in 38 countries worldwide.

Lunit has recently obtained FDA clearance for Lunit INSIGHT CXR Triage for 
emergency disease triage and Lunit INSIGHT MMG for breast cancer detection.

Lunit plans to expand its solution lineup to include the AI biomarker platform 
Lunit SCOPE and other AI software, such as Lunit INSIGHT Chest CT and Lunit 
INSIGHT DBT for breast tomography.


SOURCE: Lunit