A Roadmap to Implement a Quality Management System

  title={A Roadmap to Implement a Quality Management System},
  author={Derek Flood and Fergal McCaffery and Valentine Casey},
In recent years the proportion and comple xity of software in medical devices has increased c onsiderably. This has presented an opportunity for software deve lopment organisations to expand into the medical de vice domain. Due to the high level of risk associated wi th medical devices, strict regulations must be adhe red to in order to market such products. One key aspect of these regulations is the necessity to have in plac e a Quality Management System to help ensure an organis ations… CONTINUE READING