The Engineering Framework for Automated Vision Inspection in High-Risk Medical Devices: ISO 13485 Pathways and Practical Steps
Framework orientation and trade-show grounding Start with a clear schema: define product family, critical-to-quality features, and the automated vision inspection functions that control them. This piece uses a modular framework—requirements, architecture, verification, validation, and post-market traceability—so engineers can map each activity to ISO 13485:2016 clauses. Practical context comes from Shanghai events where manufacturers demo systems;…