L
Lbrager
When developing a new medical device intended for FDA approval and CE marking, when does R&D stop and Design Engineering start? In particular, for Design Control purposes at what point are you officially designing and developing and no longer in R&D? We are developing an IVD product shared by 3 different business units (assay, instrument, software) and it is difficult to delineate tasks by department (R&D vs. Engineering). It seems there is a lot of overlap. I am trying to determine a clear milestone for determining when design control would begin - after feasibility in theory, but again what activities are truly feasibility vs. actual design and development?