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.
 
Elsmar Forum Sponsor

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?
 
Thread starter Similar threads Forum Replies Date
S Do you test the download and installation of a mobile medical device app? Software Quality Assurance 6
K Supplier or outsourced? Medical Device installation, sales, training Other ISO and International Standards and European Regulations 7
T FDA UDI Question - Class II Medical Device Other US Medical Device Regulations 0
blackholequasar ISO 13485 certification prior to Medical Device Manufacturing... worth it? ISO 13485:2016 - Medical Device Quality Management Systems 4
P Brexit Germany - Import Medical Device For Clinical Study EU Medical Device Regulations 0
M Medical Device Marketing Material - Control of Social Media 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Ed Panek Make sure you hire competent QA RA Folks before making a "Medical Device." Coffee Break and Water Cooler Discussions 1
B Acquired Medical Device Product Line - Documentation Requirements for Device Master Record ISO 13485:2016 - Medical Device Quality Management Systems 7
MedicalDevicesCanada How to find a medical device contract manufacturer, MDSAP certified? Canada Medical Device Regulations 4
dgrainger Informational MHRA's Software and AI as a Medical Device Change Programme UK Medical Device Regulations 0
S Medical Device - Technical Documentation structure EU Medical Device Regulations 1
LostLouie Archived Specifications and Drawings for Medical Device Technical Files EU Medical Device Regulations 4
B Reprocessing of an accessory for a medical device EU Medical Device Regulations 4
A Class 1 medical device - Thailand Other Medical Device Regulations World-Wide 0
P Interchangeable/alternative parts in BOM (medical device) Manufacturing and Related Processes 4
U Is Initial Importer Status Required if a Medical Device is Manufactured and Sterilized by an OEM in the US Other US Medical Device Regulations 1
J Shoe Covers - medical device class I EU Medical Device Regulations 3
J Software as a Medical Device - SaMD IEC 62304 - Medical Device Software Life Cycle Processes 3
C CE Marking - Medical Device Accessories EU Medical Device Regulations 0
H Existing cloud based medical device - questions regarding improving the processes IEC 62304 - Medical Device Software Life Cycle Processes 6
K Unused Service Parts in Newly Manufactured Medical Device? Other US Medical Device Regulations 1
B A.I diagnostic software is considered as medical device in FDA? US Food and Drug Administration (FDA) 5
J Medical device repairs (to upholstery) Manufacturing and Related Processes 4
Ed Panek Apple Provides New Medical Device Cautions 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
C Does a medical device active (zinc oxide) needs BPR registration in EU? Other ISO and International Standards and European Regulations 5
DanBOS Cloud Connected Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
dgrainger Informational DRAFT: The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 UK Medical Device Regulations 1
S Obsolescence of the Medical Device in Various Countries Other Medical Device Related Standards 1
A IT-NETWORK in PEMS Sub-Clause 14.13 for Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
G Medical Device - Borderline/Definition EU Medical Device Regulations 0
S Medical device equipment calibration Qualification and Validation (including 21 CFR Part 11) 1
P European Medical Device Nomenclature (EMDN) and CND EU Medical Device Regulations 4
S Reseller Request to Change UPC on Medical Device via Re-labeling Medical Device and FDA Regulations and Standards News 5
D Hand Held medical device - power supply requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
E Medical device applicability to WEEE Other ISO and International Standards and European Regulations 2
Fjalar Spare parts for discontinued MDD compliant class I medical device EU Medical Device Regulations 4
H Medical Device Label Acceptance Criteria Manufacturing and Related Processes 4
J Calling a medical device a medical device (when it might not be one..) UK Medical Device Regulations 29
B Regulatory Affairs Certification (RAC) Book - Fundamentals of Medical Device Regulations Medical Device and FDA Regulations and Standards News 0
N Medical device name in different countries EU Medical Device Regulations 4
V Medical Device Literature Translation Software ISO 13485:2016 - Medical Device Quality Management Systems 1
Z Over The Air (OTA) updates for medical device Other US Medical Device Regulations 1
H Tukery Medical Device Regulstion Other Medical Device Regulations World-Wide 0
M Medical device certificate in Australia - ARTG certificate Other Medical Device Regulations World-Wide 0
Q Software as a medical device vs software not sold as medical device: local regulations for sale? EU Medical Device Regulations 4
H Medical device Product Registration Registrars and Notified Bodies 2
A Can a power Supply be an accessory to a medical device, if it is an 'off-the-shelf' product. IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
A Medical device labelling Date of manufacture US Food and Drug Administration (FDA) 3
W Non Sterile Medical Device Environmental Tests Other Medical Device Related Standards 4
A Clinical assessment sample size - Medical device Class IIb implantable (93/42 directive) EU Medical Device Regulations 2

Similar threads

Top Bottom