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.

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Case Studies—Lessons from the Field

  • Marcos Kauffman

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.