Medical devices - Quality management systems - Requirements for regulatory purposes (First revision) (ISO 13485:2016, IDT)
This Malaysian Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support).
This Malaysian Standard can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
Published
• (none) / (none) / MS ISO 13485:2006
PDF
04/05/2020
48
NSC 18 - Medical Devices and Facilities for Healthcare
