What is the definition of Installation that requires Record Keeping vs Set-up



Can someone explain what is the definition of Installation that requires record keeping vs Set-up for Medical Device.



Super Moderator
I'm not aware of any actual definition. The scope is wide so it would be difficult to nail down any specifics.

Since you posted in the 820 forum, I'll assume (just) US.

Based on the regulation, I would suggest that if you have someone (company rep / service tech) install the equipment, a record would be expected.

Are there things that could go wrong in install / setup that could lead to patient / operator hazards? If so, then (from a risk-based approach) you'd probably WANT a record.

Never a bad idea to document (with rationale) your decision.

Oscar Wang

Agree with yodon. In my opinion, a installation record is required only because the on site assembly process will introduce some safety risks into the system, just like manufacturing record DHR.


As a part of Validation, the IQ records is the proof that the installation of the equipment has been done in an acceptable manner and can be commissioned for use.
Set-up is about tool, and equipment parameter that get to be established based on the OQ / PQ performed and its records, every time you begin a batch, or make a change.
We can have several set-up for various devices on a single equipment.
Installation is one output of validation (Equipment readiness)
Set-up is the use of validated process parameters (from OQ/PQ) every time a relevant batch is processed on the installed equipment


I agree with Yodon, but would expand a little bit. There is probably a definition of "installation" in ISO9002:1994 but I don't have a copy of that. There is no definition of "installation" in the US FDA regulations that I can find and 13485 points to 9000.

You might, in your own SOPs, differentiate between "installation" and "unpacking". If your company provides delivery and unpacking services, but the unpacking does not involve any performance testing or calibration, I'd say that is not installation. But if the delivery and unpacking includes any calibration, adjustment, connection to AC mains, or anything that might affect the performance and safety of the device, then consider that installation and keep records. By having this in your own SOP, you at least demonstrate that you've considered it, even if an auditor doesn't agree with your conclusion.
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