合规语境下的医疗器械行业数字化转型思考

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.

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。

作者简介：岳磊，通信作者，高级工程师，硕士，主要从事制造运营管理标准化与信息系统技术理论。卢铁林，正高级工程师，博士后，主要从事标准数字化与智能装备研发。