CE Marking is a mark applied to products sold in the European Community indicating that the products conform to the required regulatory standards for safety and environmental protection legislation. The letters “CE” are an initialism of French phrase “ConformitÃ© EuropÃ©ene” (“European Conformity”).
An ISO 9001:2000 certificate proves that your Quality Management System has been certified against a best practice standard and found compliant. Issued by a third party certification body/registrar, the certificate lets customers know they can trust that you have implemented the necessary internal processes to meet obligations.
ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.