V
Varman04
Hi All,
Help me understand if according to the new harmonized 62366 standards for medical devices usability, If I have a CE marked medical device and I want to apply 510(k) for the US, can I use the same summative usability test report and vice versa? Does either of the institutions expect summative studies to be repeated with local population users?
Please clarify
Help me understand if according to the new harmonized 62366 standards for medical devices usability, If I have a CE marked medical device and I want to apply 510(k) for the US, can I use the same summative usability test report and vice versa? Does either of the institutions expect summative studies to be repeated with local population users?
Please clarify