Hello,
If a medical device has key performance attributes is there any requirement that the manufacturer must prove the device is capable of meeting said performance limits throughout the devices service life? My understanding is that a manufacturer must prove that essential performance and basic safety must be maintained over the service life but I am unsure about other performance limits (e.g. limits documented in the manual) which are narrower than the essential performance limits?
e.g.
Manual states oxygen is controlled to +/- 1 lpm but essential performance is determined to be +/- 5 lpm.
Thanks for any guidance.
If a medical device has key performance attributes is there any requirement that the manufacturer must prove the device is capable of meeting said performance limits throughout the devices service life? My understanding is that a manufacturer must prove that essential performance and basic safety must be maintained over the service life but I am unsure about other performance limits (e.g. limits documented in the manual) which are narrower than the essential performance limits?
e.g.
Manual states oxygen is controlled to +/- 1 lpm but essential performance is determined to be +/- 5 lpm.
Thanks for any guidance.