> 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/medcrypt-documentation/msi/check-estar-readiness/generate-submission-documents.md). # Generate submission documents The **Deliverables** page collects the regulatory documents you produce for a device. Use **Document Generation** to create standard submission documents, such as an MDS2 or a Cybersecurity Management Plan, from your device's documents instead of writing them by hand. The other tabs track your postmarket plan and forecast when your submission will be ready. ## Before you begin * Select the device and device version you're preparing documents for. * Upload the device's documents and attach their collections to the device. Generated documents draw from every document in the attached collections. ## Generate a document from a template 1. In the sidebar, select **Deliverables**. The **Document Generation** tab opens by default. 2. Under **Generate from a template**, find the document you need: | Template | What you get | | --------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------- | | **MDS2** | The Manufacturer Disclosure Statement for Medical Device Security, a standard Yes/No/N/A form that hospitals ask device makers to complete. | | **Labeling** | Joint Security Plan Document / product labeling narrative output. | | **Premarket Cyber Gap Analysis** | A premarket cybersecurity documentation gap analysis against FDA guidance, as a Word document filled in place. | | **Cybersecurity Management Plan** | A Word document describing how you'll manage cybersecurity across the device's life, filled from the device's documents or as a blank template. | 3. Select **Generate**. For the Cybersecurity Management Plan, choose **Generate with guided questions** to fill it from your documents, or **Generate blank template** to get the template with its instructions and placeholders to fill in yourself. 4. Find the document under **Recent generations** and select **Download** when it's ready. Filter the list by document type, or select **Refresh** to update it. You can leave the page while documents generate. ### Answer questions for a Cybersecurity Management Plan When you choose **Generate with guided questions**, a **Cybersecurity Management Plan needs your input** panel opens while MSI reads your documents. 1. Answer each question. Where your documents state a value, it's preselected as recommended, with the quote and its source. You confirm every commitment the plan makes to the FDA, and you approve each drafted section. 2. If you can't answer a question, select **I don't know**. The placeholder stays in the exported document as a highlighted to-do. 3. Facts MSI found with high confidence are listed under **Filled from your documents**. You can still change them. 4. Select **Finish & generate**. To skip the questions, select **Skip questions & generate**. Only values found in the device's documents go in. Drafted sections are included but marked unreviewed with a comment, and everything else stays as a to-do. ## Fill your own template If a customer or regulator gives you their own form, MSI can fill it from your evidence. 1. Under **Custom template**, select **Upload & build**. 2. Upload your template. Supported formats are .xlsx, .xlsm, .csv, .docx, .txt, and .md. An .xlsx template is filled in place; other formats produce a new Q\&A spreadsheet. 3. Optional: enter a **Display name (optional)**. 4. Select **Parse with AI**. MSI drafts a list of the template's questions and where each answer goes. 5. On **Review draft**, check the questions and their cell mapping, and fix anything that's wrong. 6. Select **Approve & generate**. ## Check your postmarket plan The **Post Market** tab shows your **Postmarket Cybersecurity Plan**: what the FDA expects you to do after the device is on the market, and how many of those requirements are currently met for this device. Requirements are grouped into **Vulnerability management**, **Timed reviews**, **Communications**, **Software & change governance**, and **Response & remediation**. Each item shows **Met** or **Not met**. Use the links, such as **Open SBOM**, **Open Vulnerabilities**, or **Open Threat Model**, to go to the screen where you can close the gap. ## Plan your delivery The **Delivery Plan** tab forecasts when your submission will be ready. It tracks each stage from **Document Import & Ingestion** through **Threat Model Run** and **Risk Register Completion** to the **eSTAR Submission Package**, using the progress MSI already has for the device version. * The summary shows your **Projected submission** date, **Schedule**, and **Completion estimate**. * Switch between the **Table** and **Timeline** views. * In the table, assign an **Owner** to each stage and check its **Health**: **On schedule**, **At risk**, **Slipping**, or **Complete**. * To set your own dates, open the options menu, select **Edit planned & projected dates**, make your changes, and select **Save dates**. To go back to the calculated plan, select **Reset all dates to derived plan**. ## Edit a document in MSI You can make quick edits to Word, spreadsheet, and text documents in your collections without downloading them. 1. Open the document from **Documents**. 2. Select **Edit**, make your changes, and select **Save**. PDFs and images open read-only. Legacy .xls spreadsheets can be viewed but not edited. ## Next steps * [Check eSTAR readiness](/medcrypt-documentation/msi/check-estar-readiness.md): confirm your documents cover the eSTAR cybersecurity requirements. * [Find and close compliance gaps](/medcrypt-documentation/msi/check-estar-readiness/find-and-close-compliance-gaps.md): track what's still missing and respond to FDA requests with AINN Analysis. * [Triage risks in the Risk Register](/medcrypt-documentation/msi/review-your-threat-model/triage-risks-in-the-risk-register.md): finish your risk review before generating risk documents. --- # Agent Instructions This documentation is published with GitBook. GitBook is the documentation platform designed so that both humans and AI agents can read, navigate, and reason over technical content effectively. 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