This is an international quality management system standard for the medical device industry. It specifies quality management system requirements when an organization needs to demonstrate its ability to supply medical devices and ensure that related services consistently meet customer and regulatory requirements. The standard is intended for organizations involved in the design, development, production, installation, servicing and distribution of medical devices.
As the medical device sector is highly regulated worldwide, the primary purpose of ISO 13485 is to facilitate harmonized regulatory requirements for medical devices. ISO 13485 is a stand-alone standard. Although it is based on ISO 9001, it also includes specific medical device requirements such as risk analysis, sterile manufacturing and traceability. At the same time, certain ISO 9001 requirements that are not mandatory from a regulatory perspective are excluded.
Organization wishing to certify its management system completes the application form established by LST Sert and submits it by email to aldona.ramanauskiene@lstsert.lt , tel. (+370 5) 270 93 56
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