The misunderstanding and countermeasures of the risk management of medical device production enterprises

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  1. The misunderstanding and countermeasures of the risk management of medical device production enterprises
    The purpose of the risk management of medical device is to control the risk of medical device products at the acceptable level, which is an important measure to ensure the safety and effective product safety and effective measures. The following is the misunderstanding and countermeasures of the risk management of medical device manufacturers brought to you. Welcome to read.
    Risk management misunderstandings
    1.1 products can meet the requirements of risk management as long as the registration standard (now technical requirements) n The manufacturer's awareness of risk management is blurred. Standards (now technical requirements) can be used, no risk analysis and risk control are required, let alone information feedback after production and production. During the actual review, it was found that the enterprise applied for registration did not understand the nature of risk management. Only the management procedures for meeting the requirements of product registration standards. The template or other products are modified slightly. It is just a formal document. The risk management of the registered product is in vain.
    1.2 Risk management is just a link for product registration
    The design, research and development, clinical, manufacturing, sales, installation, use and maintenance, and even scrap of the entire life cycle of medical devices will be based on There is a certain probability that fails and causes risks. Therefore, risk management always runs through the entire process of the entire life cycle of the medical device. YY/T0316-2008 (equivalent to using SO13485-2003) requires not only the risk in the design process during the implementation of the entire product, but also the risks generated during the procurement and production process and the information after production into risk management must be incorporated into risk management Go, eventually integrate risk management and become an indispensable part of the enterprise quality management system.
    In registration reviews, most manufacturers believe that risk management is a risk analysis, which is only an important part of product registration; or just risk before listing; some companies do not even know that the life cycle of medical device products does not know the life cycle of medical device products. meaning. In the lack of production and production information in the provided risk management report, especially risk control measures after listing, the risk analysis and control measures produced in the process of product manufacturing are lacking. Product quality system management is disconnected. At the same time, after the implementation of a specific risk control can cause a new risk, there is a tendency to push all the remaining risks to the user. This situation is very similar to the investigation of the risk management of production enterprises.
    1.3 Risk management does not require all members to participate
    The project content with risk management such as formulating risk management plans, establishing management goals, allocation of resources, and dividing responsibilities is very similar to quality management system management. Be involved together. Although many companies have realized that risk management needs all members after years of risk management practice, they have not been implemented in the specific practice of risk management. Not all participating "risk management" [3]. As everyone knows, after the design and development process, the risk analysis, risk control and measures verification in the process of design and development do not indicate that the product risk has been eliminated, but it needs to invest more energy and time for product risk management. It is necessary to fully consider many influencing factors such as production technology, production environment, use environment, target customer group and customer feedback, related laws and regulations requirements, and input these as a continuous improvement of management cycle as risk management.
    . Another prominent problem is that many companies lack the participation of clinical personnel among members of the risk management team, and clinicians have the most right to speak and effective in the safety and effectiveness of medical devices. Medical equipment is a marginal discipline involving multiple disciplines such as mechanical and electrical engineering and clinical medicine. It needs to be closely coordinated by R

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