ISO 13485-2016 《Medical Devices - Quality Management Systems - Requirements For Regulatory Purposes》 Related products

ISO 13485-2016 specifies the requirements for a mass management system for medical devices, applicable to all life cycle stages of medical apparatus design, production, storage, distribution and service. This standard highlights the capabilities that organizations need to meet customer and regulatory requirements, including product design, production control and Service support. It provides a set of management requirements for medical apparatus production and service in line with international standards, aimed at improving product mass and meeting regulatory requirements. Organizations can adapt their mass management system to their own needs to ensure compliance with the requirements of this standard.