Femasys Demonstrates Compliance with Harmonized Regulatory Requirements for Multiple Countries

Femasys Inc., a biomedical company focused on addressing unmet needs for women worldwide, has announced its successful completion of the annual Medical Device Single Audit Program (MDSAP) surveillance audit. The company achieved this milestone with no nonconformances or findings, demonstrating its commitment to compliance and quality.

Femasys currently holds Certificates of Registration for MDSAP from TUV SUD America Inc., a recognized Auditing Organization and Notified Body. This certification allows Femasys to meet the harmonized regulatory requirements for Australia, Brazil, Japan, Canada, and the United States. Additionally, the company has obtained ISO 13485 Quality System Certification for the commercialization of its products in the U.S., Canada, and Japan, with the potential to seek market authorization in Australia and Brazil.

Kathy Lee-Sepsick, the founder, president, and CEO of Femasys, expressed her satisfaction with the successful audit and highlighted the robustness of the company’s Quality System. She emphasized Femasys’ commitment to compliance and its dedication to advancing innovative technologies for women globally.

Femasys is known for its portfolio of in-office, accessible solutions aimed at meeting significant unmet needs for women. Among its notable products is FemBloc®, a late-stage clinical candidate for permanent birth control, offering a non-surgical, in-office alternative at a lower cost compared to traditional surgical methods. Femasys’ FemaSeed® has received clearance from the United States Food and Drug Administration (FDA) for infertility treatment and has also been approved in Canada.

In addition to these products, Femasys has developed diagnostic solutions that have received regulatory approvals in the U.S., Canada, and other territories. These include FemVue® for fallopian tube assessment, FemCath® for selective fallopian tube evaluation, and FemCerv® for cervical cancer diagnosis.

Femasys continues to prioritize the development and commercialization of innovative solutions for women’s health, with a focus on accessibility and improved patient outcomes. With its recent compliance achievements, the company is well-positioned to expand its reach and positively impact women’s lives globally.

For more information about Femasys and its products, visit www.femasys.com or follow the company on X, Facebook, and LinkedIn.