Health and medical device
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ISO 13485 medical device quality management system
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ISO 13485 is a standard that stipulates the requirements for the quality management system of organizations providing design and development, production, installation and additional services of medical device.
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ISO 15378 Primary packaging materials for medicinal products
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ISO 15378:2017 is a standard for primary packaging materials for medicinal products and also non-accredited standard developed to prove a quality management system to an organizations who supply materials. Primary packaging materials are packaging materials that directly contact the contents such as pharmaceuticals, medical devices and cosmetics. It includes glass, plastic, rubber, and aluminum.
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ISO 14155 Clinical investigation of medical devices for human subjects — Good clinical practice
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‘ISO 14155 is 'Clinical investigation of medical devices for human subjects - Good Clinical Practice (GCP)', which provides guidelines for clinical investigation principles, procedures to be carried out, and information to be collected.
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