Case Studies—Lessons from the Field
摘要
Three detailed case studies—Robusta Automotive (assembly robots), GreenSteel (predictive maintenance), and KineticMed (medical device quality control)—demonstrate how diverse manufacturers tackled risk classification, documentation, human oversight, and post-market monitoring. Cross-case analysis distils common success factors (early supplier alignment, intuitive operator interfaces) and pitfalls (data bias, under-scoped risk assumptions). The narratives translate theory into practice and offer sector-specific benchmarks for readers planning their own compliance journeys.