ISO 13485 is a harmonized standard for the directive 93/42/EEC.Įurofins Medical Device Testing network of laboratories operates as accredited Certification Bodies according to ISO 13485 Quality Management System for Medical Devices. In addition to product compliance, medical device manufacturers have to provide evidence that they have fulfilled the requirements of ISO 13485 a process-oriented, medical device industry-specific, Quality Management System (QMS) standard.
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