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MS ISO 13485:2006 (CONFIRMED:2013)
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.
1st Confirmation
• (none) / (none) / (none)
PDF
07/06/2019
69
NSC R - Medical Devices and Facilities for Healthcare
03.120.10 11.040.01
105.00