Explore the Handbook
What is P4SaMD?
Learn how P4SaMD supports compliant Software as a Medical Device development across the full lifecycle.
🚀Getting Started
Log in, select your organization, and navigate the platform for the first time.
🏢Organizations & Multi-Tenancy
Understand how to switch between organizations and manage per-tenant settings.
📋Products & Projects
Create and manage medical device software projects with full lifecycle governance.
📝Requirements
Capture, organize, and trace software requirements through design and verification.
🔄Brownfield Import
Onboard existing software projects and run automated compliance gap analysis.
What's New in v3
Version 3 is a complete re-architecture of P4SaMD. Here are the key changes.
Standalone Platform
P4SaMD v3 runs independently — no longer embedded in any third-party platform. A dedicated UI built specifically for compliance governance.
Learn more →Multiple Organizations
A single installation serves multiple independent organizations simultaneously, with complete database-level data isolation between tenants.
Learn more →Native Work-Item Management
Requirements, risks, tests, and changes are managed natively inside P4SaMD. No external ALM tool required — Jira and others are now optional.
Learn more →Multiple Projects per Organization
Manage all your medical device software projects in one place. Each project has its own team, compliance context, and version history.
Learn more →Brownfield Import & Gap Analysis
Onboard existing software through a guided wizard, then receive an automated compliance gap analysis and prioritized remediation plan.
Learn more →Self-Service Configuration
Organizations configure projects, integrations, and settings autonomously — without requiring Mia-Care to intervene.
Learn more →📖 FAQ
Find answers to common questions about P4SaMD capabilities, compliance, and deployment.
Read FAQ →📦 Release Notes
Stay up to date with every version of P4SaMD, including patch-level improvements.
View release notes →🔒 Security & Roles
Understand user roles, permissions, and the authentication model used in P4SaMD v3.
View roles →