The compliance bottleneck ends here.
Organizations developing Software as a Medical Device spend 6–12 months in regulatory validation for every release. P4SaMD embeds compliance directly into your workflow; making audit-readiness the default, not the deadline.
leading to missed diagnosis
Trusted by
healthcare organizations worldwide
Compliance is slowing your team down.
It shouldn't.
Fragmented tools
Jira, ALM, GitHub, Word, Excel... every team operates in its own silo.
Manual handoffs
Every transfer between systems is manual, error-prone, and invisible to auditors.
Last-minute compliance
Releases slip and regulatory submissions arrive with gaps that take weeks to resolve.
One platform. Compliant by design, fast by default.
P4SaMD integrates your existing development tools into a single compliant workflow, so your team ships faster without adding compliance overhead.
Design freeze, faster.
Connected Workflows Across Your Toolchain
Jira, GitHub, GitLab, and your ALM feed a single traceability layer automatically. No manual exports. No reconciliation at audit time.
AI Copilot for Compliant Development
An embedded AI copilot flags gaps and suggests risk mitigations in real time, keeping artifacts aligned with your QMS while code is written, not after.
Automated Regulatory Documentation
IEC 62304-compliant docs generated directly from your development activity: plans, architecture, V&V records, and traceability matrices. All automatic.
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
Compliant with EU and US Regulations
Built for every stage of the SaMD journey.
Whether you're remediating legacy software, certifying an AI model, or building from scratch — P4SaMD has a proven path.
SaMD Greenfield Development
Building a SaMD from scratch means two simultaneous challenges: writing the software and satisfying the regulator. P4SaMD makes them the same phase.
Building High-Risk AI Software (CDSS)
AI-based clinical software evolves dynamically, but traditional compliance models assume requirements are static. P4SaMD decouples your engineering velocity from regulatory rigidity.
Legacy Regulated Software Remediation
Regulatory debt is locking your legacy software. P4SaMD clears the path to certification, without rebuilding from scratch.
Every company carries the weight of regulated software.
MedTech Giants
Modernize legacy software estates into a unified, compliant platform.
Life Sciences Enterprises
Pharma and biotech launching digital companions and PSPs alongside drug releases.
AI-Native Scaleups
Series B to IPO-stage teams shipping clinical AI models without slowing engineering velocity.
Pre-Market Startups
Seed to Series A teams building their first DHF on the path to FDA clearance.
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 →