Getting Started
This guide covers your first session in P4SaMD, from logging in to navigating your first project.
Before you begin
- Your organization has an active P4SaMD subscription (SaaS or on-premise).
- A P4SaMD administrator has created your user account and added you to at least one organization.
- You have a welcome email with the URL of your P4SaMD instance and your login credentials.
Log In
- Navigate to the P4SaMD URL provided by your administrator.
- On the login screen, enter your username and password.
- Complete multi-factor authentication if your organization has configured it.
P4SaMD then checks which organizations your account belongs to and continues automatically.
Select Your Organization
If your account belongs to more than one organization, a selection screen appears after login. Each card shows the organization name and your role within it.
- Click an organization card to enter it.
- Your selection determines which projects, users, and data are visible for the rest of your session.
If your account belongs to exactly one organization, P4SaMD skips this screen and takes you directly to the Products page.
Switch organizations at any time with the organization switcher in the top navigation bar. Your session data is saved, so you return to the same context when you switch back.
Explore the Products Page
After selecting an organization, you land on the Products page, the hub for all software projects in your organization.
Each product card shows:
- Project name and description
- Project type (Standard or AI-Powered)
- Latest version name and status
- Software safety classification (Class A, B, or C)
- Applicable regulatory framework (e.g., EU MDR, FDA)
Entering a project: click any product card. P4SaMD loads the project dashboard with the most recent workspace version.
Pinning a project: hover over a card and click the pin icon to add it to the Pinned Projects section of the left sidebar.
Navigate the Project
Inside a project, the left sidebar lists the available tools. Which sections you see depends on your subscription plan and role.
| Sidebar Section | Purpose |
|---|---|
| Dashboard | Overview of project health, compliance status, and recent activity |
| Requirements | Manage and trace software requirements |
| System Design | Define and document your software architecture |
| Risks | Identify, assess, and mitigate software risks |
| Verification & Validation | Manage test plans and test cases |
| Changes | Track and manage change requests |
| Versions | Manage workspace versions and release workflows |
| Documentation | Generate compliance documentation and reports |
| AI Inventory | Manage AI/ML components, model versions, and AI-specific compliance workflows (AI-Powered projects only) |
Click the sparkles icon in the top bar to open Whisper, the in-platform AI assistant. It surfaces compliance suggestions for the current version and answers questions in a chat. Whisper appears once an administrator enables AI features for your organization. See AI Configuration.
Create or Import a Project
Starting a new project from scratch
- On the Products page, click Create New Project.
- Fill in the project details: name, description, type (Standard or AI-Powered), intended use statement, target market region, regulatory frameworks, and safety classification (IEC 62304 Class A, B, or C).
- Click Create. P4SaMD creates the project and opens its dashboard.
Bringing in an existing system (Brownfield)
To bring an existing software system into P4SaMD:
- In the left sidebar, click Brownfield, then click + Import Project on the Sessions page.
- Follow the Brownfield Import wizard.
- After the wizard completes, P4SaMD performs a compliance gap analysis and generates a remediation plan.
See Brownfield Import for the full walkthrough.