ISO 13485:2016 Medical Devices Quality Management Systems
ISO 13485:2016 Medical Devices QMS courses help learners understand regulatory requirements, risk management, process control, product safety, documentation, and continual improvement.
Description
The ISO 13485:2016 Medical Devices Quality Management Systems course group provides learners with a practical understanding of quality management requirements for organisations involved in the medical device lifecycle. These courses introduce the key requirements of ISO 13485:2016, including regulatory compliance, risk-based thinking, design and development controls, supplier management, production and service provision, traceability, validation, monitoring and measurement, nonconforming product control, corrective action, and continual improvement.
Learners will gain insight into how a Medical Devices Quality Management System helps organisations consistently provide safe and effective medical devices that meet customer, statutory, and regulatory requirements. The courses emphasise process control, documented information, product safety, risk management, accountability, and evidence-based decision-making. This course group is suitable for employees, quality professionals, regulatory affairs teams, production teams, design and development teams, internal auditors, managers, suppliers, and implementation teams involved in establishing, maintaining, improving, or auditing a Medical Devices Quality Management System.
