Full Description

ISO 13485:2016 Plus Redline specifies requirements for a quality management system that can be used byan organization involved in one or more stages of the life-cycle of a medical device, including design anddevelopment, production, storage and distribution, installation, servicing and final decommissioningand disposal of medical devices, and design and development, or provision of associated activities (e.g.technical support). The requirements in this International Standard can also be used by suppliers orother external parties providing product (e.g. raw materials, components, subassemblies, medicaldevices, sterilization services, calibration services, distribution services, maintenance services) to suchorganizations. The supplier or external party can voluntarily choose to conform to the requirements ofthis International Standard or can be required by contract to conform.

Product Details

Published: 11/01/2016 Number of Pages: 46 File Size: 1 file , 960 KB