shimonv
Trusted Information Resource
Hi all,
Below is the definition of Complaint from QSR 820.3:
"Complaint means any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution."
Below is the definition of Complaint as appears in ISO 13485, section 3.4:
"written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety or performance of a medical device that has been placed on the market."
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My question is: how do you process input from a beta site? Do you treat it as a complaint or do you use internal R&D SOP process?
To make it more interesting, would you treat it differently if the beta site is for a product with a previous regulatory clearance (i.e. modification for an approved product) as apposed to a site for validation of a novel feature.
Thanks,
Shimon
Below is the definition of Complaint from QSR 820.3:
"Complaint means any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution."
Below is the definition of Complaint as appears in ISO 13485, section 3.4:
"written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety or performance of a medical device that has been placed on the market."
====\\
My question is: how do you process input from a beta site? Do you treat it as a complaint or do you use internal R&D SOP process?
To make it more interesting, would you treat it differently if the beta site is for a product with a previous regulatory clearance (i.e. modification for an approved product) as apposed to a site for validation of a novel feature.
Thanks,
Shimon