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

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。

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.