This document describes the latest device details and as well as details for previous device versions.
Regulatory references:
Use this template to give you an idea of the necessary structure and contents. Ideally, this documentation is maintained best in a spreadsheet / excel file format. Think of every heading as a separate sheet / tab.
Fill out the table below for every installed device version. For example (in B2B business), use one row to describe every customer site the software device is installed at.
| Device Name | Product Status | Release Date | Purpose | Device Identifier (DI) | Product Identifier (PI) | Customer Details | Customer Point of Contact | App Store URL | Commentary |
|---|---|---|---|---|---|---|---|---|---|
| <enter device name> | <released / in trial / etc.> | (…) | <e.g. clinical use> | (…) | (…) | (…) | (…) | (…) | (…) |
Use the table below to document your device’s versions history.
| Device Name | Device Version | Release Date | Decommissioning Date | Device Identifier (DI) | Product Identifier (PI) | Commentary |
|---|---|---|---|---|---|---|
| <enter device name> | V.1.1 | (…) | (…) | (…) | (…) | (…) |
| <enter device name> | V.1.0 | (…) | (…) | (…) | (…) | (…) |
| Product Name | Manufacturer | Country of Origin | Additional Information | Device Identifier (DI) |
|---|---|---|---|---|
| <enter device name> | (…) | (…) | (…) | (…) |
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