Femasys Inc (FEMY)

[dande1990]

– Femasys demonstrates compliance with harmonized regulatory requirements for Australia, Brazil, Japan, Canada and the USA –

– Femasys(FEMY) is committed to bringing innovative solutions to women around the world –

ATLANTA, Oct. 03, 2023 (GLOBE NEWSWIRE) -- Femasys Inc.(FEMY) , a biomedical company focused on meeting significant unmet needs for women worldwide with a broad portfolio of in-office, accessible solutions, including a lead late-clinical stage product candidate and innovative diagnostic products, today announced that it has successfully completed the annual Medical Device Single Audit Program (MDSAP) surveillance audit with no non-conformances and no findings.

Femasys (FEMY) currently holds Certificates of Registration for MDSAP from TUV SUD America Inc., a recognized Auditing Organization and Notified Body that conducts a single regulatory audit of medical device manufacturers that satisfies the relevant harmonized regulatory requirements for the countries participating in the MDSAP program, and ISO 13485 Quality System Certification for the commercialization of Femasys(FEMY) products in the U.S., Canada and Japan with the ability to register for market authorization in Australia and Brazil.

“Completion of the MDSAP annual surveillance audit with no non-conformances and no findings demonstrates the robustness of the Femasys Quality System and our continued commitment to compliance that extends to all of our in-house manufacturing capabilities,” said Kathy Lee-Sepsick, founder, president and chief executive officer of Femasys(FEMY). “We look forward to continuing to advance our much-needed innovative technologies in the U.S., as well as other countries around the world, via the MDSAP program."

Femasys (FEMY) is creating accessible innovative options for women, as exemplified by its lead product candidate, FemBloc® in late-stage clinical development for permanent birth control and its now-United States Food and Drug Administration (FDA)-cleared product, FemaSeed® for infertility treatment (also approved in Canada). The Company is commercializing complementary diagnostic products that were internally developed through its in-house manufacturing capabilities, with regulatory approvals in the U.S., Canada and other ex-U.S. territories.

$FEMY