SEOUL, South Korea, Sept. 13, 2023 /PRNewswire/ — AIRS Medical Inc., an AI-powered healthcare solution provider headquartered in Korea announces the attainment of MDSAP (Medical Device Single Audit Program) certification. This milestone achievement underscores AIRS Medical’s commitment to quality excellence on a global scale, further propelling the company’s flagship product, SwiftMR™, towards an accelerated trajectory of international expansion.
MDSAP certification confirms the comprehensive achievement of regulatory audit requirements and compliance standards for medical device manufacturers looking to sell products within the United States (FDA), Canada (HC), Japan (MHLW), Australia (TGA), and Brazil (ANVISA).
The MDSAP certification stands as a testament to AIRS Medical’s adherence to top-tier quality management practices. This endorsement signifies that AIRS Medical’s quality management system has met the exacting standards set forth by the MDSAP regulatory framework.
One of the key advantages of the MDSAP certification lies in its potential to expedite product approvals and market access. By streamlining the regulatory processes across multiple jurisdictions, AIRS Medical Inc. can now navigate the complex landscape of global markets with heightened efficiency. This acceleration in regulatory clearance is expected to facilitate the international expansion of SwiftMR™, the company’s renowned AI-powered MRI enhancement solution.
"At AIRS Medical, we’ve always been driven by a commitment to excellence and innovation," says Hyeseong Lee, CEO of AIRS Medical. "The MDSAP certification reinforces our commitment to providing the highest quality of care through the digital transformation of the healthcare experience."
SwiftMR™ has already garnered widespread recognition for its ability to reduce the scan time and enhance image quality through Deep-learning technology. With the newly acquired MDSAP certification, SwiftMR™ is poised to extend its positive impact across borders, ensuring patients and healthcare providers around the world can benefit from its capabilities.