ISO 13485 (Medical Devices) Frequently Asked Questions
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ISO 13485 is a voluntary standard that outlines the requirements for a quality management system (QMS) for medical devices.
ISO 13485 is designed to be used by organisations involved in the design, production, installation, and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.
This blog post covers some of the most frequently asked questions in relation to ISO 13485.
Added on: 09 October 2024