The right plan for every stage of your SaMD journey.
No hidden costs. All plans include direct access to our regulatory experts.
Standard
Small teams getting started
The foundation you need to build your first SaMD with compliance from day one.
- ✓1 company · 3 projects · 5 users
- ✓SDLC Workflow Orchestrator
- ✓Requirements & Risk Management
- ✓Documentation Engine (standard templates)
- ✓BOM & Change Management
- ✓On-demand support
- ✓5M tokens / month
Professional
Growing teams scaling compliance
Custom insights, automated AI/ML compliance, and tool validation for teams moving fast.
- ✓1 company · 5 projects · 10 users
- ✓Everything in Standard
- ✓Custom Smart Insight
- ✓Custom documentation templating
- ✓AI/ML Compliance Pack (automated)
- ✓Pre-validation package
- ✓Whisper — AI Assistant
- ✓Integrations & MCP Server
- ✓Ticketing support
- ✓50M tokens / month
Unlimited
Enterprises & multi-product organizations
Unlimited scale, eQMS integration, and dedicated support for the most complex regulated environments.
- ✓Unlimited companies, projects & users
- ✓Everything in Professional
- ✓AI-assisted legacy updates
- ✓Full eQMS integration
- ✓Support for audit readiness
- ✓24/7 AI + Dedicated Lead
- ✓500M tokens / month
Compare plans
| Standard | Professional | Unlimited | |
|---|---|---|---|
| Companies | 1 | 1 | Unlimited |
| Projects | 3 | 5 | Unlimited |
| Users | 5 | 10 | Unlimited |
| Legacy Support | Basic metadata import & gap identification | Remediation plan | AI-assisted legacy updates |
| Smart Insight | Default | Custom | Custom |
| Documentation | Standard Technical Files | Custom templating for diverse market regions | Full integration with eQMS |
| AI/ML Compliance Pack | Limited | Automated | Automated |
| Tool Validation | — | Pre-validation package | Support for audit readiness |
| Support | On-demand | Ticketing | 24/7 AI + Dedicated Lead |
| Token / Month | 5 M | 50 M | 500 M |
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
- ✓SOC 2-aligned environment
Self-Hosted
Unlimited planFull 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
- ✓Supports air-gapped and hospital networks
- ✓Custom security and compliance configurations
Frequently asked questions.
Do you offer a free 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 under GAMP 5?
Yes. The platform is built and maintained following GAMP 5 principles, making it suitable for use in ISO 13485-controlled environments.
How does pricing work for the Unlimited plan?
Unlimited pricing is tailored to your organization's size, number of projects, integration requirements, and support needs. Contact our team for a custom quote.
Ready to ship compliant software faster?
Join the teams building the next generation of regulated medical software.
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