Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,

I am looking for some guidance on installation records.  As background, I work for a medical device manufacturer who generally does not sell directly to the end customer.  Instead, we work through distributors that purchase and install our product at the end customer's address.  It is also possible that the distributor we sell to has sub-distributors that actually interface with the end customer and conduct the installation. 

Our company has established dealer agreements with our direct distributors that clearly specify our expectations for installation records, such as:

• the installing company is required to maintain installation records for all product installed to meet the FDA QSR and ISO 13485 requirements
• install records shall be made available upon request.

We also provide installation guides to describe how the product should be installed and installation verified.  It is a low-risk product (US Class 1), so generally the "verification of install" focuses more on ensuring electrical connections, etc, were made appropriately and the product will actually turn on.  There is low risk to patient/user if the product is installed incorrectly.

Due to the extensive nature of our distributor network and low risk nature of the product, we do not currently provide an installation checklist for the installer to fill out and return.  Our preferred approach would be to allow the installer to record the installation and verification of install in the way that best suits their process, as long as they include the needed information and records can be provided upon request.

The questions we have are:

1. Is having a sales order, associated invoice, and record of payment by the end customer sufficient to show that the installation was acceptable (e.g. "verification of installation") for a low risk device?
2. If not, what is the minimum evidence needed on the install record for "verification of installation?"
3. Is the installer's signature required on the record?

Thank you

This message was posted by a user wishing to remain anonymous

Any thoughts or guidance on this?  We are interested in learning from others' experience in this situation.

Thank you
Original Message:
Sent: 20-Sep-2017 17:26
From: Anonymous Member
Subject: Installation Records

This message was posted by a user wishing to remain anonymous

Hello,

I am looking for some guidance on installation records.  As background, I work for a medical device manufacturer who generally does not sell directly to the end customer.  Instead, we work through distributors that purchase and install our product at the end customer's address.  It is also possible that the distributor we sell to has sub-distributors that actually interface with the end customer and conduct the installation. 

Our company has established dealer agreements with our direct distributors that clearly specify our expectations for installation records, such as:

• the installing company is required to maintain installation records for all product installed to meet the FDA QSR and ISO 13485 requirements
• install records shall be made available upon request.

We also provide installation guides to describe how the product should be installed and installation verified.  It is a low-risk product (US Class 1), so generally the "verification of install" focuses more on ensuring electrical connections, etc, were made appropriately and the product will actually turn on.  There is low risk to patient/user if the product is installed incorrectly.

Due to the extensive nature of our distributor network and low risk nature of the product, we do not currently provide an installation checklist for the installer to fill out and return.  Our preferred approach would be to allow the installer to record the installation and verification of install in the way that best suits their process, as long as they include the needed information and records can be provided upon request.

The questions we have are:

1. Is having a sales order, associated invoice, and record of payment by the end customer sufficient to show that the installation was acceptable (e.g. "verification of installation") for a low risk device?
2. If not, what is the minimum evidence needed on the install record for "verification of installation?"
3. Is the installer's signature required on the record?

Thank you