Z
I work for a medical device manufacturer in the US - our products are CE-marked. I am finishing up our revised Vigilance Reporting procedure and am struggling to come up with a reportability decision tree... MEDDEV 2.12-1 Rev 4 had one in it - but one is not present in Rev 5...
Has anyone seen one? Or do you have one you'd be willing to share?
Anyone else feel like Rev 5 is less clear and more difficult to implement than Rev 4 was?
TIA for any input/assistance!!
*Laurie
Medical Device Regulatory Affairs Manager
Has anyone seen one? Or do you have one you'd be willing to share?
Anyone else feel like Rev 5 is less clear and more difficult to implement than Rev 4 was?
TIA for any input/assistance!!
*Laurie
Medical Device Regulatory Affairs Manager
