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Introduction to medical devices: overview on market and regulations. Nomenclature and standards. Medical devices in the EU regulation.
Medical devices regulation. The new approach, directives and guidance documents, regulatory process, the involved parties (authorities, officials, notified bodies, end users), requirements and compliance.
CE marking, conformity assessment and declaration of conformity, labelling and e-labelling, traceability
Quality management systems for medical devices. Quality management systems and medical devices. Technical standards ISO 13485 and ISO/TR 14969
Risk Assessment and Management. Definitions and standards. Techniques for risk assessment. The technical standard ISO 14971:2007. Software risk management and human factors in MD industry
Medical Device Packaging. The technical standard UNI EN ISO 11607:2006
Six Sigma for Medical Devices. Quality process, control charts, process capability, Design Of Experiment, Quality Function Deployment
Medical Device Reliability and maintenance of medical devices
Managing stocks and service levels for medical and health systems