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Vegas CG is a global leader in Consultancy, Training, HR Outsourcing, Testing and Certification, enabling the client to achieve high quality services
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ISO 13485 Certification ISO 13485 is an individual QMS standard that is derived from ISO 9000 standard series which is recognized and accepted internationally. It adapts the ISO 9000 model based on process into a regulated environment for manufacturing medical devices.ISO 13485 is a more prescriptive in nature and often does require a rather thorough documentation of the QMS system.While retaining the Plan, do, check concepts of ISO 9001, It is designed for regulatory compliance.
ISO 13485 certificates are renown and trusted in industries involved in medical devices and manufacturers, suppliers and authorities around the world. ISO 13485 was transcribed singularly to manufacturers of their designing of quality management systems that effectivelyestablish and maintain their processes. It ensures the consistency design and development, production, delivery and installationof medical devices in a manner that is safe for their intended purpose. .
Benefits of ISO 13485 Certification Certification increases access to worldwide markets Process review and improvement outline across your organization Monitor supply chain performance, increase efficiency and cut costs. Demonstration of safer and effective medical device production. Meeting customer expectation and Regulatory requirement.
