Femasys announces completion of MDSAP surveillance audit

Femasys has completed the annual Medical Device Single Audit Program surveillance audit with no nonconformances and no findings. Femasys 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 products in the U.S., Canada and Japan with the ability to register for market authorization in Australia and Brazil.