ISO 14971
ISO 14971 is a key standard for risk management of medical devices. ISO 14971:2019 describes the requirements for risk management throughout the life cycle of a medical device. The purpose is to ensure the safety and performance of the product within the intended use defined by the manufacturer.
Regulations such as MDR and IVDR require consideration of risk management in the operations of organization during the life cycle of a medical device. As part of the organization’s daily operations, risk management aims to ensure controlled solutions and operations in all circumstances.
The ISO 14971 standard can be used to make sure that medical devices that end up on the market are effective and safe, and users and patients are informed about their possible residual risks.
There is a connection between ISO 14971 and ISO 13485 standards. ISO 13485 (as well as the general safety and performance requirements of MDR and IVDR) require well-described and functional risk management. Together, ISO 14971 and ISO 13485 form a functional quality and risk management system that protects equipment users from risks.
To obtain the ISO 13485:2016 certificate, the organization must apply a risk-based approach to managing the processes required by the quality management system. The ISO 14971 standard supports the risk analysis of devices and the recording of risks in accordance with the ISO 13485 standard.
Regulations such as MDR and IVDR require consideration of risk management in the operations of organization during the life cycle of a medical device. As part of the organization’s daily operations, risk management aims to ensure controlled solutions and operations in all circumstances.
The ISO 14971 standard can be used to make sure that medical devices that end up on the market are effective and safe, and users and patients are informed about their possible residual risks.
There is a connection between ISO 14971 and ISO 13485 standards. ISO 13485 (as well as the general safety and performance requirements of MDR and IVDR) require well-described and functional risk management. Together, ISO 14971 and ISO 13485 form a functional quality and risk management system that protects equipment users from risks.
To obtain the ISO 13485:2016 certificate, the organization must apply a risk-based approach to managing the processes required by the quality management system. The ISO 14971 standard supports the risk analysis of devices and the recording of risks in accordance with the ISO 13485 standard.