Regulatory pathway (FDA/CE) help
Posted under your company
Software-as-a-medical-device, unsure if we're Class II or exempt. Want someone who's taken a SaMD product through FDA recently.
A health or device company wants help mapping a regulatory pathway.
A request reads like this. The answers become the details, so someone can tell at a glance whether they can help.
Posted under your company
Software-as-a-medical-device, unsure if we're Class II or exempt. Want someone who's taken a SaMD product through FDA recently.
Every regulatory pathway (fda/ce) help request answers the same questions: product type, regulatory body, classification question and timeline.
A regulatory-affairs professional with relevant clearance experience. The button they see says Map the regulatory path.
Posted under your company. Close it when you have what you need.
Sample written for this page. It is not a real request.