ISO 13485 is an important regulatory standard created by the International Organization for Standardization (ISO). It is important for organizations involved in the design, production, installation, and servicing of medical devices and related services. As regulatory requirements become more demanding and the life science industry becomes more complex, the standard can help organizations create a more compliant, effective, and efficient quality management system. The PathWise ISO 13485 training for medical device manufacturing online course covers outlines key areas, including the emphasis on risk management and risk-based decision making.