医疗器械软件质量技术标准研究
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摘要
基于现阶段医疗器械法规的要求,对医疗器械软件合规性、类别,文档的完整性、系统的标准性及临床的有效性等进行探讨。医疗器械软件制造商需强化法规要求,将医疗器械法规要求融入软件技术标准中,持续改进产品,保证医疗器械软件质量,确保医疗器械产品的安全性、有效性。
Based on the requirements of current medical device regulations, medical device software compliance, categories, document integrity, system standardization and clinical effectiveness are discussed. Medical device software manufacturers need to strengthen regulatory requirements, integrate medical device regulatory requirements into software technology standards, continuously improve products, ensure the quality of medical device software, and ensure the safety and effectiveness of medical device products.
Based on the requirements of current medical device regulations, medical device software compliance, categories, document integrity, system standardization and clinical effectiveness are discussed. Medical device software manufacturers need to strengthen regulatory requirements, integrate medical device regulatory requirements into software technology standards, continuously improve products, ensure the quality of medical device software, and ensure the safety and effectiveness of medical device products.
引文
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[2]马莉,杜堃,何涛.医疗器械软件模型的研究和测评规范的初步建立[J].中国医疗器械杂志,2017(1):59-62.
[3]牟鹏涛.对我国医疗器械软件监管工作的思考和建议[J].医疗装备,2018(11):200-202.
[4]国家食品药品监督管理总局.总局关于发布医疗器械网络安全注册技术审查指导原则的通告[Z].2017-01-20.
[5]彭亮,郑佳,余新华.医疗器械软件标准体系建设探讨[J].中国医疗设备,2015,30(3):59-62.
[6]肖忆梅,母瑞红.我国医疗器械标准体系基础数据库的建立与思考[J].中国医疗器械信息,2011,17(10):58-61.