The regulatory agencies are very strict in enforcing the standards the medical manufacturing sector as these products are straight connected to the health and safety of the clients. There many standards of conformity that must be complied by the manufacturers of medical devices in order to make sure the delivery only the best quality of products to the clients. It is designed and planned for use by organizations for the design and development, production, installation, servicing and sales of medical devices. It specifies needs for a quality management system where an organization requirements to demonstrate its capability to give medical devices, and that related services constantly meet client needs and applicable regulatory requirements. ISO 13485:2012 is the globally known standard for quality management systems in the medical device industry. ISO 13485:2012 Medical Devices - Quality Management Certification
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