Reflection on the Digital Transformation of the Medical Device Industry in the Compliance Context
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.
digital transformationmedical deviceregulationoperation excellencequality best practices
国家科技期刊平台
NSTL
万方数据
维普
