ISO 13485
Medical Devices
ISO 13485 is the internationally recognized standard for quality management for medical devices. It shows commitment to the quality management of medical devices and related services in the medical industry. Amtivo is accredited for ISO 13485 by the ANSI National Accreditation Board (ANAB).
What is ISO 13485?
ISO 13485 is an international standard developed by the International Organization for Standardization (ISO) that defines the requirements for a Quality Management System (QMS) in the medical industry, covering medical devices and related services. The standard helps organizations consistently comply with regulatory requirements and meet client expectations, by offering a framework to enable quality design, manufacture, and installation of medical devices worldwide.
Find out about the benefits of ISO 13485, the certification journey, FAQs and more, below.