The ISO 13485 certification represents evidence of Quality Management System in compliance to standard for organizations involved in the Medical Device industry
ISO 13485 focuses on the harmonization of the Quality Management Systems in the framework of Medical Device regulatory requirements. Most Regulatory Authorities and Associations recognize or require that Medical Device Manufacturers, Representatives, Importers and Distributors alike to obtain ISO 13485 certification in order to access their market.
For more information, email us at firstname.lastname@example.org.
Note: We are currently undergoing the application process with SAC, will be available soon. Do approach us to find out more.