SANS 13485 Certification for Medical Devices

Strengthening Quality, Safety, and Compliance in South Africa’s Medical Device Industry

SABS proudly offers SANS 13485 certification, a quality management system (QMS) standard, specifically developed for organisations involved in the design, development, production, installation, and servicing of medical devices and related services.

SANS 13485 provides a comprehensive framework to help organisations consistently meet customer, regulatory, and industry requirements, ensuring that medical devices are safe, effective, and reliable.

Aligned with international standards such as ISO, SANS 13485 supports South African companies in demonstrating global compliance and building trust within both local and export markets.