GaleMed announced it has successfully obtained Medical Device Single Audit Program (MDSAP) certification on Sep. 3rd., 2025. This milestone underscores the company's dedication to maintaining a robust quality management system and achieving seamless compliance with the stringent regulatory requirements of the participating countries.

The MDSAP certification process involved a comprehensive audit by a recognized Auditing Organization, confirming that GaleMed's quality management system meets the international standard of ISO 13485 and the specific requirements of regulatory authorities in markets including the United States, Canada, Japan, Brazil, and Australia. This single, unified audit process demonstrates the effectiveness and consistency of GaleMed's operational processes and its commitment to global regulatory standards.

GaleMed remains committed to providing users with high-quality products and services. For more information, please contact your GaleMed representative or email sales@galemed.com.