A three day course addressing the concepts, science and practical methods of bringing devices to market more efficiently.
For the first time AAMI is bringing its three day Human Factors for Medical Devices course to Europe. Led by Dr Robert North and Dr Edmund Israelski, it includes direct representation from the US FDA's Office of Device Approvals.
Featuring detailed 'do' and 'don't' insights into the process of applying Human Factors Design controls into medical devices, the course is said to cover all major aspects of integrating, applying, analysing and testing Human Factors in the medical device development process. It also provides insights into – and comparisons between – the harmonisation of global regulatory standards, streamlining your device submission process, how to meet HE-74, HE-75 and IEC-62366 standards and the best ways to obtain premarket clearances in the US.
