Medical devices and IVD systems are developed with the purpose of assisting health care providers diagnose and treat patients to overcome sickness or disease to, in the end, improve their quality of life. Therefore, it is essential that medical devices and IVD systems...
Are you ready for the Clinical Laboratory Improvement Amendments waiver? With the large market for laboratory devices growing fast, the benefits of designing for the waiver are even more important for better and faster patient care. For manufacturers, it vastly...
Imagine a medical device development team has done preliminary analyses on who will be using the device, determined the environment in which the device will be used, and defined key device user interfaces. A use-related risk analysis was performed, which exposed...
