Hello.
Actually I have to deal with discussions about complaint handling...
If a medical device is sent back from customer to the manufacturer because of a defect AFTER the device's specified lifetime has expired - is it a requirement to treat this as a complaint acc. §820.198?
If yes - where can i find a corresponding regulatory requirement?
Any comment is appreciated!
Thanks in advance for your feedback and support!
BR
Aphel
Actually I have to deal with discussions about complaint handling...
If a medical device is sent back from customer to the manufacturer because of a defect AFTER the device's specified lifetime has expired - is it a requirement to treat this as a complaint acc. §820.198?
If yes - where can i find a corresponding regulatory requirement?
Any comment is appreciated!
Thanks in advance for your feedback and support!
BR
Aphel