T
Hi folks,
I am in the mist in defining the lifetime of the medical devices. It is understand that medical devices have its own lifetime. But how to define the lifetime of the medical devices that can last long in the market although it has consume throughout the lifetime of the patient (ie. bone screws, plates, nuts, hospital locker, hospital cabinet, hospital beds and etc.). It is due to the retention period of the records which required by the ISO 13485, it is important to define the lifetime of the medical devices and it will impact on the retenrion period of the records. Furthermore, it is mandatory requirement to define in the Quality Manual and Standard Operating Procedure.
Is there anyone have this experience that can explain and help me?
Millions of thanks!
Tiffany
I am in the mist in defining the lifetime of the medical devices. It is understand that medical devices have its own lifetime. But how to define the lifetime of the medical devices that can last long in the market although it has consume throughout the lifetime of the patient (ie. bone screws, plates, nuts, hospital locker, hospital cabinet, hospital beds and etc.). It is due to the retention period of the records which required by the ISO 13485, it is important to define the lifetime of the medical devices and it will impact on the retenrion period of the records. Furthermore, it is mandatory requirement to define in the Quality Manual and Standard Operating Procedure.
Is there anyone have this experience that can explain and help me?
Millions of thanks!
Tiffany