https://www.taxtmi.com/article/detailed?id=17151 ISO 13485:2016 establishes a specialised quality management system framework for medical-device lifecycle organisations, centred on regulatory conformity, patient safety, process control, traceability, documented evidence and continual improvement. It requires lifecycle risk management through risk identification, evaluation, control and monitoring. Core controls include documented quality processes, management and resource responsibility, design and development verification and validation, manufacturing and supplier controls, sterilisation and packaging safeguards where applicable, and performance evaluation through audits, complaints, monitoring, corrective and preventive action. en-us Tue, 11 Aug 2026 08:48:23 +0530 Tue, 11 Aug 2026 08:48:23 +0530 TaxTMI RSS Generator https://www.taxtmi.com/article/detailed?id=17151 ISO 13485:2016 establishes a specialised quality management system framework for medical-device lifecycle organisations, centred on regulatory conformity, patient safety, process control, traceability, documented evidence and continual improvement. It requires lifecycle risk management through risk identification, evaluation, control and monitoring. Core controls include documented quality processes, management and resource responsibility, design and development verification and validation, manufacturing and supplier controls, sterilisation and packaging safeguards where applicable, and performance evaluation through audits, complaints, monitoring, corrective and preventive action. Articles Other Topics Tue, 11 Aug 2026 08:48:23 +0530 https://www.taxtmi.com/article/detailed?id=17151