Medical Device Installation Records from Third Party Installer

L

Lasers

#1
Hi,
We are manufacturer of medical devices in EU and we are importing devices in US through distributor. He has his own service network that also provide installation of our devices at customers.
Must we as manufacturer according CFR 820.170 also have installation records copies? Can FDA inspector demand to see installation records from third party installers during FDA inspection in our company or not?
Thanks.
 
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sreenu927

Quite Involved in Discussions
#2
When your distributor is performing "installation" activities, who is compiling the procedures/forms of IQOQPQ? I guess it would be you providing your distributor all the IQOQPQ forms along with the instrument (shipment).
Upon successful installation, you have to get the installation records from your distributor.

See below excerpts from 21 CFR 820:

Sec. 820.170 Installation.
(a) Each manufacturer of a device requiring installation shall establish and maintain adequate installation and inspection instructions, and where appropriate test procedures. Instructions and procedures shall include directions for ensuring proper installation so that the device will perform as intended after installation. The manufacturer shall distribute the instructions and procedures with the device or otherwise make them available to the person(s) installing the device.

(b) The person installing the device shall ensure that the installation, inspection, and any required testing are performed in accordance with the manufacturer's instructions and procedures and shall document the inspection and any test results to demonstrate proper installation.

Sec. 820.180 General requirements.
All records required by this part shall be maintained at the manufacturing establishment or other location that is reasonably accessible to responsible officials of the manufacturer and to employees of FDA designated to perform inspections. Such records, including those not stored at the inspected establishment, shall be made readily available for review and copying by FDA employee(s). Such records shall be legible and shall be stored to minimize deterioration and to prevent loss. Those records stored in automated data processing systems shall be backed up.

Regards,
Sreenu
 

Haresh

Involved In Discussions
#3
When your distributor is performing "installation" activities, who is compiling the procedures/forms of IQOQPQ? I guess it would be you providing your distributor all the IQOQPQ forms along with the instrument (shipment).
Upon successful installation, you have to get the installation records from your distributor.

See below excerpts from 21 CFR 820:

Sec. 820.170 Installation.
(a) Each manufacturer of a device requiring installation shall establish and maintain adequate installation and inspection instructions, and where appropriate test procedures. Instructions and procedures shall include directions for ensuring proper installation so that the device will perform as intended after installation. The manufacturer shall distribute the instructions and procedures with the device or otherwise make them available to the person(s) installing the device.

(b) The person installing the device shall ensure that the installation, inspection, and any required testing are performed in accordance with the manufacturer's instructions and procedures and shall document the inspection and any test results to demonstrate proper installation.

Sec. 820.180 General requirements.
All records required by this part shall be maintained at the manufacturing establishment or other location that is reasonably accessible to responsible officials of the manufacturer and to employees of FDA designated to perform inspections. Such records, including those not stored at the inspected establishment, shall be made readily available for review and copying by FDA employee(s). Such records shall be legible and shall be stored to minimize deterioration and to prevent loss. Those records stored in automated data processing systems shall be backed up.

Regards,
Sreenu
Dear Sreenu,
Thanks for above valuable information.
I just have one question is installation and service provider shall have ISO 13485 certification though the priniciple or OEM company provides the required documentation/reports for execution of installation and service activities at the customer of principle company or OEM?
 
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