The Design Input section of the Medical Device Quality Systems Manual: A Small Entity Compliance Guide mentions the need to have a final device specification which covers all the device characteristics.
Our company does not have such a document, since our DHF and DMR include all the pertinent information, for example including a very detailed Design Input document.
I just wanted to ask you regulatory experts out there whether this is sufficient for an FDA inspector.
Thanks
Mandy
Our company does not have such a document, since our DHF and DMR include all the pertinent information, for example including a very detailed Design Input document.
I just wanted to ask you regulatory experts out there whether this is sufficient for an FDA inspector.
Thanks
Mandy
