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Mia-Care P4SaMD
01 — SDLC

SDLC Workflow Orchestrator

From fragmented tools to a single compliant workflow.

Connects and orchestrates existing best-of-breed SDLC tools (Git, ALM, eQMS, IDPs) for the implementation of a fully IEC 62304-compliant SDLC. No rip-and-replace. No disruption to engineering culture. Just compliance, built into how your team already works.

What It Does

Your tools. Your stack. Compliance guaranteed.

Most teams already have the tools they rely on: GitHub for code, Jira or other ALMs for task management, an eQMS for quality records. The problem is that these tools rarely speak the same language as a regulatory auditor. P4SaMD bridges that gap without asking your team to change the way they work.

Beyond connecting your existing toolchain, P4SaMD enforces the correct workflow sequence across the entire development lifecycle: requirements before design, design before implementation, implementation before verification. Skipping a mandated step becomes structurally impossible.

Key Features
Tool Orchestration

Connect without migrating

P4SaMD integrates with your existing Git repositories, ALM tools, and eQMS without requiring migration to a proprietary system. Your team keeps their tools; the platform adds the compliance layer on top.

Blueprint Engine

IEC 62304 workflow templates

Pre-built workflow blueprints for each software safety class (A, B, C) encode the correct IEC 62304 lifecycle phases and required artifacts, so teams always know what to do next, and auditors always find what they expect.

Config Management

End-to-end change control

Every configuration item is tracked with full change history, approval records, and version lineage. When a regulator asks who approved this change and what was the impact assessment, the answer is instant.

Seamless Integration

No rip-and-replace

Built for the reality of enterprise engineering. P4SaMD works alongside your existing tool stack with lightweight connectors, no forced migrations, no retraining, no disruption to the releases already in flight.

Standards Addressed

Built to satisfy the standards that matter most to your auditors.

IEC 62304ISO 13485EU MDR 2017/745ISO 14971FDA

Ready to ship compliant software faster?

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