One can debate the reasons for varying lead times—demand exceeds capacity, not enough people to run machines, etc.—but at the end of the day,
people make things happen.
Due to the presence of higher-than-acceptable levels of ethylene oxide in the air, FDA is exploring ways to validate new sterilization agents or processes. About half of all sterilized medical devices in the U.S. undergo sterilization using ethylene oxide.
NuVasive completed limited clinical release testing of its Pulse™ platform, validating that its structural design supports broad clinical utility and is usable in 100% of spine surgeries.
Management Review, a regulatory requirement, can be a value-added experience with thoughtful accountability, expected responsibility and successful compliance.
