Extract to table

SBD, as the design origin and manufacturing entity, will retain responsibility for quality management at the manufacturing site in Dublin and must ensure that its processes and documentation meet all applicable U

requirements diverge from or supplement EU MDR requirements, and Solstice must ensure that its systems are adapted accordingly

Reports of deaths must be submitted to FDA within thirty (30) calendar days of the date the manufacturer becomes aware of the information

Reports of serious injuries must also be submitted within thirty (30) calendar days of awareness

A manufacturer must report to FDA any malfunction of a device it markets that would be likely to cause or contribute to a death or serious injury if the malfunction were to recur

Malfunction reports must be submitted within thirty (30) calendar days of awareness