What is medical device risk management system certification?
ISO 14971, as a risk management system standard for the medical device industry, specifies the risk management principles and risk management specifications mentioned in several major international standards for medical devices (such as IEC 60601-1 electrical safety, IEC 62366 usability engineering, ISO 10993 biological evaluation, and IEC 62304 software life cycle process), which comply with the provisions of ISO14971. For China, the United States, the European Union, Japan It is of great significance for medical device manufacturers in Australia and other international markets to seek regulatory permission. An effective risk management system can support the design, development, production and sales of various types of medical devices and post market risk management, so as to create and protect value.
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The NCE ISO 14971:2019 risk management certification relies on the advanced experience of international certification bodies and is established by the expert team according to the needs of medical device manufacturers. Through in-depth understanding of the risk management principles and processes, it pays attention to integrating the risk management requirements of applicable medical device regulations and standards into the product design and quality management system, which helps medical device organizations to do a good job in risk management throughout the product life cycle; Promote the improvement of the quality of medical devices, which is conducive to entering the domestic and international markets.
　　
What is the scope of ISO14971 quality system certification?　　
ISO14971 standard certification is carried out synchronously with iso13485:2016 standard, integrating risk management requirements into all links of the quality system, and operation is also penetrated into daily operation and maintenance. These requirements can be adopted by organizations participating in one or more stages of the life cycle of medical devices, including the design and development, production, storage and sales, installation, service, final shutdown and disposal of medical devices, And the design, development or provision of relevant activities (such as technical support). The requirements of this international standard can also be used by suppliers or other external parties providing products (such as raw materials, accessories, components, medical devices, sterilization services, calibration services, distribution services and maintenance services). Suppliers and external parties may voluntarily choose to comply with the requirements of this international standard or in accordance with the requirements of the contract.

Relationship between ISO13485 and ISO14971 system certification and current regulations
NCE certification integrates the current "medical device production quality management specification" and the appendix and inspection guiding principles of corresponding products, as well as iso14971:2019 "Application of medical device risk management to medical devices" into the scope of management system certification audit. It is clear that iso13485:2016 and ISO14971 standards and integration into current regulations are effective solutions to meet the comprehensive requirements of QMS. Through ISO 13485 and ISO14971 certification, regulations and standards are integrated for one-time audit, which provides a practical basis for certified enterprises to meet medical device directives, regulations and commitments to product safety and quality.
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ISO 13485 and ISO14971 certification can help you improve the overall quality system and risk system level, control the post marketing risk of medical devices within an acceptable range, continuously improve quality management and product risk control and expand market opportunities by collecting post marketing information. Obtaining this certification is the quality management and risk management commitment of the organization to customers and regulators.