A Roadmap to Implement a Quality Management System

In recent years the proportion and complexity of software in medical devices has increased considerably. This has presented an opportunity for software development organisations to expand into the medical device domain. Due to the high level of risk associated with medical devices, strict regulations must be adhered to in order to market such products. One key aspect of these regulations is the necessity to have in place a Quality Management System to help ensure an organisations’ ability to consistently meet customer and regulatory requirements. This paper presents a roadmap which can be used to assist organisations, wishing to develop medical device software to implement a Quality Management System.