Medical devices - Quality management systems - Requirements for regulatory purposes (Including COR. 1:2009) (ISO 13485:2003, IDT)
This Malaysian Standard specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services.
Withdraw
MS ISO 13485:2006 is superseded and replaced by MS ISO 13485:2017 Medical devices - Quality management systems - Requirements for regulatory purposes (First revision) (ISO 13485:2016, IDT)
PDF
18/12/2024
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NSC 18 - Medical Devices and Facilities for Healthcare
