随着国家和民众对于医疗器械安全性问题的日益关心，国家和地方对于行业企业科学化、数字化监管提出了更高的要求。然而，由于当前缺乏覆盖企业质量体系风险的量化指标，制约了监管部门和企业的数字化监管能力。本研究基于医疗器械生产质量管理规范的“人机料法环”框架，构建关键工艺、关键环境、关键人员、关键供应商、可追溯性、不良事件管理和数据真实性等7个一级指标，以及对应的二级和三级指标的风险指标体系。通过企业和产品的特性确定指标权重，根据风险权重计算产品和企业的风险值，从而实现风险的量化评价。本研究提出指标数据类型和获取方式，特别是自动化采集技术的应用，能提高风险数据的实时性和真实性。风险指标的构建不仅为企业提供全流程风险管控工具，为监管部门智能预警提供数据支撑，推动医疗器械生产管理的数字化与标准化，也为人工智能在风险管理中的应用提供了基础。

With the increasing attention to the safety of medical devices of the state and the public， higher requirements have been put forward for the scientific and digital supervision of industry enterprises by the state and local authorities. However， the current lack of quantitative indicators covering the risks of enterprise quality systems has restricted the digital supervision capabilities of regulatory authorities and enterprises. Based on the "human-machine-material-method-environment" framework of medical device production quality management specifications， this study constructs a risk index system consisting of 7 first-level indicators， including key processes， key environments， key personnel， key suppliers， traceability， adverse event management， and data authenticity， as well as corresponding second-level and third-level indicators. The weights of the indicators are determined according to the characteristics of enterprises and products， and the risk values of products and enterprises are calculated based on the risk weights， so as to realize the quantitative evaluation of risks. This study also proposes the types and acquisition methods of index data， especially the application of automated collection technology， which can improve the timeliness and authenticity of risk data. The construction of risk indicators not only provides enterprises with full-process risk management and control tools and provides data support for the intelligent early warning of regulatory authorities， promotes the digitization and standardization of medical device production management， and also provides a foundation for the application of artificial intelligence in risk management.