Dear all,
One doubt related with the RDC no. 183 dated 17th October 2017. The definition of “finished device”, in "section III Definitions", says: "Finished device: the product, being one, a family, a system, or a set of products, which is ready for use or functionally complete, whether it is packed, labeled, or sterilized, or not"
What is understood by “functionally complete” in a sterile device?
• The sterilized and released device
• The sterilized device pending of the final release
• The packed device pending of the sterilization and final release
• Other?
As released device I understand that the device has the final approval and signature of the responsible person (usually the QA Manager).
Thanks!!
One doubt related with the RDC no. 183 dated 17th October 2017. The definition of “finished device”, in "section III Definitions", says: "Finished device: the product, being one, a family, a system, or a set of products, which is ready for use or functionally complete, whether it is packed, labeled, or sterilized, or not"
What is understood by “functionally complete” in a sterile device?
• The sterilized and released device
• The sterilized device pending of the final release
• The packed device pending of the sterilization and final release
• Other?
As released device I understand that the device has the final approval and signature of the responsible person (usually the QA Manager).
Thanks!!