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Contact SupplierWe provide iso 13485 certification. iso 13485 is an international standard that defines quality management system requirements for manufacturers of medical devices. Iso 13485:2003 provides a harmonized set of quality management system requirements for medical device manufacturers. Iso 13485 certificate can help you in entering almost any market in the world. It is currently recognized in most major markets (europe, usa, canada etc). while it is based on iso 9001, iso 13485 does not include the customer satisfaction and continual improvement clauses - so an organization certified to iso 13485 does not automatically meet the requirements of iso 9001 unless it is assessed against that standard separately. Compliance with iso 13485 also does not guarantee compliance with regulatory requirements, but it can facilitate the audit process for those requirements. so if you are thinking for iso 13485 or any other quality certification (management system or product certification)