What is P4SaMD?
P4SaMD (Platform for Software as a Medical Device) is the compliance governance platform built by Mia-Care for teams that design, build, and certify medical device software. Version 3 is a complete re-architecture: it runs as a standalone product with its own interface, independent of any other software infrastructure.
What P4SaMD Does
P4SaMD covers the full Software as a Medical Device (SaMD) development lifecycle and aligns it with:
- EU MDR (Medical Device Regulation)
- FDA regulations for software medical devices
- IEC 62304: the leading standard for medical device software development
- ISO 14971: risk management for medical devices
- ISO 13485: quality management systems for medical devices
Compliance work sits inside the development workflow, so projects stay audit-ready.
Who Uses P4SaMD?
P4SaMD supports every role in the SaMD development lifecycle:
| Role | How P4SaMD Helps |
|---|---|
| Software Engineers | Guided, IEC 62304-compliant development process with structured workflows |
| Product Owners | Link product requirements to compliance evidence, track project health, and manage version releases |
| Project Managers | Visibility into compliance status, risk posture, and project progress across all products |
| QA Engineers | Enforce quality processes, manage test plans, and track verification coverage |
| Regulatory Affairs | Manage compliance with ISO 13485, IEC 62304, and ISO 14971; generate documentation for audits and submissions |
Key Features in v3
| Feature | Description |
|---|---|
| Requirements Management | Create and organize software requirements in a hierarchical tree, with lifecycle statuses and full traceability to design and tests |
| Risk Management | Identify, assess, and mitigate software risks following ISO 14971, with guided risk estimation and links to control measures |
| System Design | Define and document your software architecture with a hierarchical Software Item model, classifying components including SOUPs and AI-based elements |
| Verification & Validation | Plan and execute test cases, manage test runs, and collect automated test evidence across unit, integration, and system levels |
| Brownfield Import | Onboard existing software projects through a guided wizard, then get an automated compliance gap analysis and remediation plan |
| Documentation Engine | Auto-generate Technical File documents (release notes, risk reports, SBOM reports and more) populated with live project data |
| Version Management | Create and manage workspace versions with structured release workflows aligned to IEC 62304 |
| Multi-Tenancy | One installation serves multiple organizations with complete data isolation between tenants |
| SDLC Orchestration | Connect your git provider, CI/CD pipeline, and toolchain to enforce compliance guardrails at the code level |
What Changed in Version 3
The most significant changes:
| Aspect | Version 2 | Version 3 |
|---|---|---|
| Deployment | Embedded in Console (shared infrastructure) | Standalone platform with dedicated UI |
| Authentication | Single Sign-On with Console | Federated OIDC authentication, independent identity provider |
| Tenancy | Single-tenant per instance | Multi-tenant: one installation serves multiple organizations |
| Work-Item Management | Required external ALM (Jira mandatory) | Native work-item management built in; external ALMs are optional |
| Project Scope | One project per instance | Multiple projects per organization |
| Self-Service | Mia-Care configures on your behalf | Organizations configure themselves through the admin portal |
Deployment Options
P4SaMD v3 supports three deployment models:
- Multi-Tenant SaaS: fully managed, shared cloud deployment with logical data isolation between organizations. Zero infrastructure to manage.
- Dedicated SaaS: dedicated cloud infrastructure per customer, for organizations that require physical database separation while keeping SaaS operational simplicity.
- On-Premise: self-hosted deployment for complete data sovereignty, air-gapped network support, and custom infrastructure requirements.
All three deployment models provide the same feature set.
Integrations
- Git providers: GitHub, GitLab (for source control and automated evidence collection)
- CI/CD: Jenkins, GitHub Actions, GitLab CI (for automated test result ingestion)
- ALM tools: Jira and others (optional bidirectional sync, no longer mandatory)
- eQMS systems: connect to your quality management system for document access