The purpose of the question is to understand whether complaints where there is suspected sterile barrier breach (ex: hole in packaging) is...
There is a definition of "malfunction" that FDA provided in their 2016 guidance on MDR reportability. The definition goes: "Malfunction means the...
It seems regulatory agencies are flagging any risk files where "detection" is used for scoring. As we know, a lot of manufacturers use FMEA in...
Separate names with a comma.