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.
Request a Demo →Most organizations treat compliance as a layer on top of engineering.
A painful translation step between how code is written and how regulations are satisfied. P4SaMD dissolves this boundary. It connects to your existing tools, orchestrates your workflows, and enforces quality controls as a natural part of your SDLC.
The platform integrates your Internal Developer Platform (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.
Compliant with
Eight capabilities. One platform.
P4SaMD orchestrates your entire SDLC — from requirements to release — with regulatory compliance enforced at every stage.
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.
Ready to ship compliant software faster?
Join the teams building the next generation of regulated medical software.
Request a Demo →