Super Brush is excited to announce it has recently achieved ISO 13485:2016 certification. ISO 13485 is a voluntary, international standard that defines quality management system (QMS) requirements for manufacturing medical devices. The standard ensures that an organization can consistently meet the applicable customer, quality, and regulatory requirements. This standard is globally recognized in all major markets around the world such as the United States of America, Europe, Canada, Japan, and Australia.
There are several benefits to achieving and maintain ISO 13485 regulation. Companies that have achieved certifications can show proof to potential clients that they comply with best practices and regulatory requirements. This ensures that Super Brush can manufacture high-quality medical device products.