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February 23, 2024
After a long wait, the U.S. Food and Drug Administration (FDA) recently published a Final Rule to harmonize the Quality System Regulation (QSR) codified at 21 C.F.R. Part 820...
February 19, 2024
On January 21, 2024, the FDA issued a final rule amending its Quality System (QS) regulations under 21 CFR Part 820, which addresses current good…
February 16, 2024
After a long wait, the U.S. Food and Drug Administration (FDA) recently published a Final Rule to harmonize the Quality System Regulation (QSR) codified at 21 C.F.R. Part 820 with the...
February 10, 2024
On February 2, 2024, the U.S. Food and Drug Administration (FDA) published a final rule amending the device good manufacturing practice (GMP) requirements of the Quality System...
February 9, 2024
On February 2, 2024, FDA finalized its nearly two-year-long process to harmonize QS regulations with ISO standards. As we mentioned when FDA proposed the harmonization in 2022, this...
October 31, 2023
Compliance with global information security management standard strengthens customer trust
October 4, 2023
Zentek Provides Corporate Update
October 3, 2023
– Femasys demonstrates compliance with harmonized regulatory requirements for Australia, Brazil, Japan, Canada and the USA –– Femasys is committed...
October 3, 2023
Femasys Inc. (NASDAQ: FEMY) shares are trading lower Tuesday.
September 13, 2023
/PRNewswire/ -- AIRS Medical Inc., an AI-powered healthcare solution provider headquartered in Korea announces the attainment of MDSAP (Medical Device Single...