标准科学Issue(2)：81-87,7.DOI:10.3969/j.issn.1674-5698.2024.02.014
合规语境下的医疗器械行业数字化转型思考
Reflection on the Digital Transformation of the Medical Device Industry in the Compliance Context
摘要
Abstract
The paper focuses on industry hotspots and deeply dives into the paradoxical nature of compliance and quality phenomena.It critically examines the FDA Quality Case Initiative,explains the dialectical relationship between compliance and quality,and introduces the concept that all regulatory and quality requirements are satisfied in one operation system.Furthermore,it provides valuable insights into digital considerations for operation excellence by presenting a case study illustrating a medical device manufacturer's successful transition from compliance-focused to quality-assured.关键词
数字化转型/医疗器械/监管/卓越运营/质量最佳实践Key words
digital transformation/medical device/regulation/operation excellence/quality best practices引用本文复制引用
岳磊,卢铁林..合规语境下的医疗器械行业数字化转型思考[J].标准科学,2024,(2):81-87,7.基金项目
本文是科技部国家重点研发计划资助项目"标准数字化重点领域应用探索研究"(项目编号:2022YFF0608005)研究成果. （项目编号:2022YFF0608005）
