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Implementation of ISO 13485 helps an organization to keep the quality and consistency of medical devices, moreover it is an assurance to their clients. The third column shows if the new medical device regulation could have some additional impact on these processes and procedures or not. ISO 13485 is a quality management system specifically designed for medical device manufactures, designers and developers which is similar to US FDA 21 CFR 820. ISO 13485:2016 is an international standard that sets out the requirements for a quality management system (QMS) specific to the medical devices industry. ISO 13485 is the medical industrys optimal medical device standard, which ensures that all medical devices meet the proper regulatory compliance laws and. The second column lists all of the affected chapters of ISO 13485:2016 for additional information. Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) General information Valid from Base Documents.
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The list below represents the main processes and procedures required by the ISO 13485:2016. It is thus the basis for companies that are in the field of medical technology. Learn how SGS can help with certification and auditor training. ISO 13485:2016 can also be used by suppliers or external parties that provide products, such as quality management system-related services to such organizations. Ensure a smooth transition to ISO 13845:2016 Medical devices Quality management systems. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities. ISO 13485:2016 specifies requirements for a quality management system of an organization that needs to demonstrate its ability to provide medical devices and related services and consistently meet customer and applicable regulatory requirements.