Page 6 - Device Single Audit Program News Today

/PRNewswire/ -- Lunit, a leading medical AI provider, announced today a preliminary approval from the Korea Exchange for initial public offering (IPO) on the...

/PRNewswire/ -- Lunit, a leading medical AI provider, announced today a preliminary approval from the Korea Exchange for initial public offering (IPO) on the...

Lunit gets greenlight to accelerate listing on the KOSDAQ marketFirst Korean healthcare company to receive AA-AA ratings in technology assessmen...

Press release content from Globe Newswire. The AP news staff was not involved in its creation.

/PRNewswire/ -- PDO Max, Inc., a leader in FDA cleared Polydioxanone (PDO) threads-in-cannula medical devices for non-surgical facial tissue repositioning, is...

The U.S. Food and Drug Administration (FDA) issued the much-anticipated proposed rule “Medical Devices: Quality System Regulation Amendments,” which will harmonize the current Quality...

The FDA is proposing to amend the current good manufacturing practice (cGMP) requirements of 21 CFR Part 820: Quality System Regulation (QSR) to...

After four long years and a series of delays, the US Food and Drug Administration released its proposed rule for amending the Quality System Regulation to be harmonized with ISO...

The FDA is proposing to amend the current good manufacturing practice (cGMP) requirements of 21 CFR Part 820: Quality System Regulation (QSR) to...

Investegate announcements from Sequana Medical NV, Sequana Medical receives certification under MDR, the new European Medical Device Regulation