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.
Building software-as-a-medical-device means navigating regulations, design control, risk traceability, and audit documentation, all while shipping on time. Most teams manage this across disconnected tools: Jira for tasks, an ALM for specifications, GitHub for code, Word for documentation, Excel for traceability matrices. Every handoff between these systems is manual, error-prone, and invisible to auditors until it's too late.
The result is predictable. Compliance becomes a last-minute scramble, releases slip, and regulatory submissions arrive with gaps that take weeks to resolve. Speed and compliance feel like a tradeoff.
See how P4SaMD fixes this →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
P4SaMD connects natively with Jira, GitHub, GitLab, and your ALM of choice. Tasks, code commits, test results, and change records flow into a single traceability layer automatically. No manual exports. No reconciliation at audit time.
AI Copilot for Compliant Development
An embedded AI copilot guides engineers through IEC 62304 requirements in real time, flagging gaps, suggesting risk mitigations, and keeping development artifacts aligned with your QMS as code is written.
Automated Regulatory Documentation
P4SaMD auto-generates IEC 62304-compliant documentation directly from your development activity: software development plans, architecture descriptions, verification and validation records, and traceability matrices.
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
Many organizations hold valuable legacy software trapped by regulatory debt. P4SaMD provides a structured path to certification without rebuilding from scratch.
Every company carries the weight of regulated software.
MedTech Giants
Enterprise organizations modernizing fragmented legacy software estates into a unified, compliant digital health platform.
Life Sciences Enterprises
Global pharma and biotech companies launching digital companions and Patient Support Programs alongside drug releases.
AI-Native Scaleups
Series B to IPO-stage companies building and continuously improving clinical AI models without sacrificing engineering velocity.
Pre-Market Startups
Seed-to-Series A teams building their Design History File and first regulated product 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 →