Products & Projects
The Products page is the organization-level hub that lists all medical device software projects in your organization. Access it by clicking All Products in the sidebar (visible when no project is selected), or by navigating up to the organization level via the breadcrumb.
Each project is shown as a card. The card displays the project name and description, the project type (Standard or AI-Powered), the name and status of the most recent workspace version, the overall compliance posture, the IEC 62304 safety classification (Class A, B, or C), and the primary target regulatory framework. Clicking a card opens the project and loads its sidebar navigation pointing to the most recent version. If you work with a project frequently, hover over its card and click the pin icon — pinned projects appear at the top of the left sidebar for one-click access from anywhere in the platform.
Creating a Project
To start a new project from scratch, click Create New Project on the Products page and fill in the form. The fields you must provide are: a project name, the project type (Standard or AI-Powered), an intended use statement in plain language, the target market region (EU, US, or other), the applicable regulatory frameworks (such as EU MDR or FDA 510(k)), and the IEC 62304 safety classification (Class A, B, or C). A description is optional but recommended.
Choosing AI-Powered as the project type enables an additional set of sidebar sections for managing AI and ML components, model versions, datasets, and AI-specific compliance workflows. This setting can be changed later by a project administrator.
Once you click Create, P4SaMD provisions the project and takes you directly to the project dashboard.
Importing an Existing Project
If you have an existing software system that you need to bring under a formal compliance process, use Import Project on the Products page to open the Brownfield Import wizard. The wizard guides you through six steps to describe the project, upload technical assets, and provide existing documentation. After submission, P4SaMD runs a compliance gap analysis and generates a prioritized remediation plan. See Brownfield Import for the full walkthrough.
Product Information
Each project has a Product page (open it from Configuration → Product in the project sidebar) showing the product's metadata and regulatory identifiers, organized into two tabs.
The Details tab shows the product name, description, intended use, software safety classification, the AI Smart Assistance toggle, target market region, and regulatory frameworks, alongside system information (created/updated timestamps and who made each change). Users with the Admin or QA role can click the edit icon in the tab bar to modify these fields; other roles see a read-only view. Some changes prompt a confirmation dialog because they could affect how the product is handled going forward.
The History tab lists every change made to the product's metadata — who made the change and when — with a filter to narrow the feed to a single field. This gives you an audit trail of the product's regulatory identity over time.
Managing Product Members
Each project has a Product Members page (open it from Members in the project sidebar) where administrators control who has access and at what role. The page shows a member table with search and a role filter, plus a stats panel summarizing the team (Active, Admin, Tech Team, and Business users).
Click Add Member to grant access: pick a user from your organization and assign a Product Role — Admin, Tech Team, Business, QA, or Viewer. The dialog includes a Show capabilities breakdown so you can see exactly what each role can do before assigning it. Removing a member is confirmed by typing their name and is blocked if it would leave the project without an Admin.
At the organization level, the same page is shown as Tenant Members for managing organization-wide membership. See Roles and Permissions for the full role model.
Where to go next