> For the complete documentation index, see [llms.txt](https://docs.medcrypt.com/llms.txt). Markdown versions of documentation pages are available by appending `.md` to page URLs; this page is available as [Markdown](https://docs.medcrypt.com/msi/get-started/create-your-first-device.md).

# Create your first device

The fastest way to get started is to upload the documentation you already have. MSI reads your documents, extracts the device's details, builds its device knowledge, and then starts its analyses for you automatically.

## Before you begin

* Select the workspace the device belongs to. A device is created in your current workspace. See [Find your way around MSI](/msi/get-started.md#switch-organization-workspace-or-device).
* Gather your device documentation. Upload everything you have: design specifications, risk analyses, test reports, SBOMs (software bills of materials) and submission materials. The more you provide, the more MSI can extract and pre-fill.

{% hint style="info" %}
**Supported file types**

* **Documents:** PDF, Word (.doc, .docx), Excel (.xls, .xlsx), PowerPoint (.ppt, .pptx), OpenDocument (.odt), Rich Text (.rtf), plain text (.txt), Markdown (.md), CSV, JSON, HTML, YAML (.yaml, .yml)
* **Diagrams:** Draw\.io (.drawio), Visio (.vsdx), XML
* **SBOMs:** SPDX (.spdx), CycloneDX (.cdx)
* **Images:** PNG, JPG/JPEG, GIF, WebP, BMP, TIFF
  {% endhint %}

## Start creating the device

1. Open the device picker. If your workspace has no devices, MSI shows **Add a device** when you open the **Dashboard**. Otherwise, select the device selector at the top of the sidebar.
2. Select **Upload Documents**. If you see the device list, select **Add Device**, then **Upload Documents**.

{% hint style="info" %}
If you'd rather type in the device details yourself, select **Add Manually** instead. MSI won't extract details from documents or start any analyses automatically.
{% endhint %}

## Add your documents

Under **Device Documentation**, drag your files onto the drop area or click it to browse. MSI creates a new document collection for them, named after the device.

If you've already uploaded these documents to a collection, select **Or choose an existing collection** and pick it instead.

If the collection shows **Documents are still being indexed**, wait for indexing to finish before you continue.

## Configure the device

Under **Device Configuration**, fill in these fields. They decide which standards apply and how threats are scored.

| Field                          | What to enter                                                                                                                                                                                                     |
| ------------------------------ | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| **Device Name**                | Optional. If you leave it blank, MSI takes the name from your documents.                                                                                                                                          |
| **Intended usage environment** | Where the device is actually used, such as **Home**, **Clinical - ICU/Critical Care** or **Laboratory**. This shapes threat modeling and audits.                                                                  |
| **Compliance Goal**            | The regulatory pathway you're working toward, such as **FDA 510(k)**, **FDA PMA**, **FDA eSTAR**, an **EU MDR** pathway, **Health Canada**, **CFDA** or **Japan PMDA**. This determines which requirements apply. |
| **Device Modification Status** | Whether this is a change to a device the FDA has already authorized. This decides which eSTAR sections your submission needs (see below).                                                                         |
| **Risk Formula**               | How MSI turns each risk's measurements into a score and a severity band (none, low, medium, high or critical). The recommended option is marked.                                                                  |

For **Device Modification Status**, choose one:

* **Yes, cybersecurity is unaffected**: a modification to an FDA-authorized device that doesn't affect cybersecurity. Only 3 eSTAR sections are required.
* **No, device was not previously authorized**: a new device. 11 eSTAR sections are required.
* **No, cybersecurity is affected**: a modification that affects cybersecurity, such as new authentication or encryption, new connectivity, or a changed software update process. 11 eSTAR sections are required.

A previously authorized device is one cleared through a 510(k), granted through De Novo, or approved through a PMA. The **Need help deciding?** box on the page gives more examples.

When every required field is filled in, select **Extract Device Info**.

## Confirm the device details

MSI reads your documents and extracts the device's details. Keep the page open until extraction finishes; your browser warns you if you try to leave while it's running.

When extraction finishes, check the details under **Confirm Device Information**. Fields MSI found in your documents are marked. Correct anything that's wrong, fill in any blanks, and select **Save**. You need to fill in these fields:

* **Device name**
* **Device class**
* **Device type**
* **Intended usage environment**
* **Connected device**

If extraction fails, select **Try Again** to go back and start over.

## Follow the processing steps

After extraction, the page shows **Processing Activities**, a list of the steps MSI runs for the new device:

| Step                    | What happens                                                                                                             |
| ----------------------- | ------------------------------------------------------------------------------------------------------------------------ |
| **Wiki Ingestion**      | MSI reads your documents and builds the device's knowledge base. The step shows how many claims it has extracted so far. |
| **Regulatory Audit**    | Checks your documents against regulatory requirements.                                                                   |
| **Threat Model**        | Identifies assets, threats and controls from your device's architecture.                                                 |
| **eSTAR Readiness**     | Checks your documentation against the FDA eSTAR requirements.                                                            |
| **Maturity Assessment** | Evaluates your cybersecurity maturity.                                                                                   |

The four analyses wait until **Wiki Ingestion** completes, then start on their own. Each shows its progress while it runs. MSI only starts the analyses your organization's plan includes.

You don't have to stay on this page. Once the analyses on your plan have finished, open the device's **Dashboard** to see the results.

## If your device is still processing

Processing continues in the background after you leave. To check on it:

* Look for **device processing…** below the device selector in the sidebar. Select it to open the device list.
* In the device list, a device that's still being created shows its status, such as **Extracting** or **Building Wiki**. Select it to view progress.
* Open the device's **Dashboard**. While its knowledge base is being built, the dashboard shows the processing steps instead of the usual cards.

{% hint style="warning" %}
If a step shows a failed status, the step's details show the reason. Other steps carry on. If you can't resolve the problem, use **Help & Support** > **Contact us**.
{% endhint %}

## Next steps

* [Understand your dashboard](/msi/get-started/understand-your-dashboard.md): see what MSI found once processing finishes.
* [Answer guided questions](/msi/get-started/answer-guided-questions.md): fill in what your documents didn't say, to improve your threat model.
* [Review and correct device knowledge](/msi/review-and-correct-device-knowledge.md): check the details MSI extracted.