Medical Device Field Service Performance Inspection Process Validation

Q

QE

Dear Coves.

I am working on a project as a QE to review and approve a plan and protocol which validates a performance inspection process performed by the service group on the devices in the field distributed by the firm. Can any one provide some specific guidance available by the FDA or something developed from their own experience please?
 
M

MIREGMGR

I don't know of specific guidance for validation of a performance inspection process, but general guidance for validation of processes is at http://www.fda.gov/MedicalDevices/D...dicalDeviceQualitySystemsManual/ucm122439.htm.

CDER, CBER, CDRH and CVM also jointly publish another guidance, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm124720.htm, which doesn't show up in searches at CDRH since it's in the CDER document structure.

And of course there's GHTF's /SG3/N99-10 at http://www.ghtf.org/documents/sg3/sg3_fd_n99-10_edition2.pdf.
 
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