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
岳磊 1卢铁林2
作者信息
- 1. 西门子工业软件(北京)有限公司
- 2. 中国科学技术信息研究所;机械工业仪器仪表综合技术经济研究所
- 折叠
摘要
本文聚焦于行业观瞻,直入探讨合规与质量的"悖论"现象,回顾了FDA质量案例计划,厘清合规与质量的辩证关系,提出在一个卓越制造运营体系中满足合规和质量要求的概念,就卓越运营的数字化考量提供管窥之见,以一例医疗器械制造商质量观念的转变,印证从"关注合规"到"保证质量"转变的可行性.
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
基金项目
科技部国家重点研发计划资助项目(2022YFF0608005)
出版年
2024
国家科技期刊平台
NSTL
维普
万方数据