The right plan for every stage of your SaMD journey.
Built for regulated teams at every stage, from first submission to global scale.
Entry
Starting from scratchEverything you need to launch your first SaMD project with compliance built in from day one.
- Greenfield only (no legacy remediation)
- SDLC Workflow Orchestrator
- Default AI/ML Compliance Pack
- Auto-generation of standard Technical Files
- Limited integrations
- No eQMS integration
- On-demand support
Standard
Small teams getting startedThe foundation you need to build your first SaMD with compliance from day one.
- Everything in Entry
- Requirements & Risk Management
- Basic Verification & Validation framework
- BOM & Change Management
Professional
Growing teams scaling complianceCustom insights, automated AI/ML compliance, and tool validation for teams moving fast.
- Everything in Standard
- Tailored Smart Insight & AI Assistant
- Custom document templating
- Full AI/ML Compliance Pack
- Legacy assessment & pre-validation package
- Integrations & MCP Server
- Ticketing support
Unlimited
Enterprises & multi-product organizationsUnlimited scale, eQMS integration, and dedicated support for the most complex regulated environments.
- Everything in Professional
- AI-assisted legacy remediation
- eQMS integration
- Support for audit readiness
- 24/7 ticketing with dedicated Lead & AI assistant
Compare plans
| Entry | Standard | Professional | Unlimited | |
|---|---|---|---|---|
| Companies | 1 | 1 | 1 | Unlimited |
| Products | 1 | 3 | 5 | Unlimited |
| Users | 3 | 5 | 10 | Unlimited |
| Legacy Support | No (greenfield only) | Basic metadata import & gap identification | Remediation plan (multi-region) | AI-assisted legacy updates |
| Smart Insight | Default | Default | Custom | Custom |
| Documentation | Standard Technical Files | Standard Technical Files | Custom templating for diverse markets | Full eQMS integration |
| AI/ML Compliance Pack | Limited | Limited | Automated | Automated |
| Tool Validation | — | — | Pre-validation package | Support for audit readiness |
| Support | On-demand | On-demand | Ticketing | 24/7 ticketing with dedicated Lead & AI assistant |
| Tokens / month | 1M | 5M | 50M | 500M |
Choose how you run it.
P4SaMD is available in two deployment models to match your infrastructure and compliance requirements.
SaaS
RecommendedFastest path to compliance
Fully managed cloud deployment. Instant provisioning, automatic updates, and zero infrastructure overhead. Available on all plans.
- ✓Instant provisioning — ready in minutes
- ✓Automatic platform updates and security patches
- ✓Shared cloud infrastructure managed by Mia-Care
Self-Hosted
Full ControlFull control over your environment
Deploy P4SaMD on your own infrastructure — private cloud or on-premise. Designed for organizations with strict data residency, sovereign cloud, or network isolation requirements.
- ✓Data never leaves your environment
- ✓Private cloud or on-premise deployment
- ✓Custom security and compliance configurations
Frequently asked questions.
Do you offer a trial?
We offer guided evaluations tailored to your regulatory context rather than a generic trial. Request a demo to start with a scoped session with our team.
Can I start with one capability and add others later?
Yes. P4SaMD is modular by design. You can begin with the SDLC Orchestrator and Guided Workflows, then expand to the full capability set as your needs evolve.
Is P4SaMD validated for Medical Device development?
Yes. The platform is built and maintained following GAMP 5 principles, making it suitable for use in ISO 13485-controlled environments.
Ready to ship
compliant software faster?
See how P4SaMD fits into your development workflow.
Request a Demo →