The AI-native Platform
for Software as a Medical Device.
Mia-Care P4SaMD unifies eQMS, ALM, and DevOps into a single platform, embedding regulatory compliance directly into your SDLC. Your team ships faster, stays audit-ready, and achieves both engineering velocity and regulatory confidence.
Compliant with
Trusted by
healthcare organizations worldwide
Most organizations treat compliance as a layer on top of engineering.
Regulatory Intelligence Layer
- Records auto-generated from SDLC
- Real-time, immutable audit trail
- Continuously audit-ready
- Requirements traced in real time
- Risks linked to mitigations & tests
- Living traceability matrix
- Guardrails enforced at every commit
- Release notes auto-generated
- DHF compiled continuously
All systems governed and audit-ready in real time — no manual effort.
P4SaMD connects to your existing tools, orchestrates your workflows, and enforces quality controls as a natural part of your SDLC, without asking your team to change how they work.
It integrates your IDP, your Catalog, and a Compliance Engine into a single cohesive execution environment, with P4SaMD as the regulatory intelligence layer that governs all of it.
Every requirement tracked. Every risk mapped. Every release documented. Continuously, automatically, in real time.
Our promise to our customers.
The full E2E in one platform.
P4SaMD orchestrates your entire SDLC — from requirements to release — with regulatory compliance enforced at every stage.
SDLC Workflow Orchestrator
One platform. Every tool. One source of truth.
- Connect without migrating
- IEC 62304 workflow template
- All your data, in one place
Ready to see P4SaMD in action?
Schedule a live walkthrough and see how P4SaMD fits your stack in under 30 minutes.
Why we are different.
Continuous Compliance
An audit-ready, fully validated platform, built on GAMP5 principles. Your development environment meets the quality standards required by global healthcare authorities from day one.
Flexibility & Modularity
P4SaMD adapts to your operational needs. It integrates into your engineering team's existing workflow, making compliance a natural part of how developers already work.
Adaptive Regulatory Reliability
The regulatory landscape never stops moving. P4SaMD evolves with it automatically, so your team can focus entirely on building what matters.
Find the right plan for your team.
From your first SaMD to enterprise-scale multi-product compliance — P4SaMD grows with you.
Ready to ship
compliant software faster?
See how P4SaMD fits into your development workflow.
Request a Demo →