1/25/2024 0 Comments Uni cei en iso 13485 2016In the European Union, the fulfillment of EU. The certification of a quality management system, specifically for medical devices, to ISO 13485 is essential, for medical companies which export their products to the global market. ISO 13485: 2016 has been harmonized against the three EU Medical Devices Directives (Medical Devices, in vitro Diagnostic Devices and Active Implantable Devices), so certification to this standard by an accredited certification body such as EMC automatically demonstrates compliance with specific clauses in these directives. Furthermore all devices are certified CE and are accordant to the European regulations in force.Įlectro medical test – photo biological test – etc ISO 13485 Quality Management System for Medical Devices is a quality management system standard specifically for the medical devices industry, which encompasses aspects of the ISO 9001 standard, plus additional industry-specific medical device requirements.
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