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Mia-Care P4SaMD
01 — SDLC

SDLC Workflow Orchestrator

One platform. Every tool. One source of truth.

Connects and orchestrates existing best-of-breed toolchain (Git Repositories, ALM, eQMS, Internal Developer Platforms) into a single unified workspace. No rip-and-replace. No disruption to engineering culture. Just compliance, built into how your team already works.

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What It Does

Your tools, connected. Your data, unified.

Engineering teams already work with the tools they trust: Git repositories for code, Jira for tasks, ALMs for specification management, an eQMS for quality records. The problem is that these tools store data in silos — and no single system holds the full picture.

P4SaMD sits at the center, ingesting data from every connected tool and maintaining a live, unified record of the entire development lifecycle. Every change, every approval, every artifact is captured in one place — so your team always works from the same source of truth, and nothing falls through the cracks between systems. The compliant workflow structure embedded across all connected tools meets IEC 62304 requirements without disrupting the way your team works.

In Action
Dashboard
SDLC
Workflow Guide
Requirements
Software System
Verification
Risk Analysis
Configuration
Tool Integrations
Audit Log
Mia-Care Dev›App Cardio-Monitor›Dashboard
App Cardio-MonitorDevelopment
Real-time cardiac monitoring application
📋 Class IIb🇪🇺 EU MDR🏷 v2.1⏳ 78% Complete
EditNew Release
⚠3 Tasks Require AttentionPriority
CRITICALBLOCKER
Document each module in detail
⏱ 7–10 days
HIGH
Document SOUP items
⏱ 2–3 days
Requirements
0
42 Verified · 26 In Progress
Test Cases
0
77% Pass Rate
Risks Identified
0
23 Mitigated · 5 Open
Software Items
0
12 SOUP · 22 Custom

Project dashboard — every active SDLC project summarised in one view. Tasks blocking the next phase are surfaced automatically with severity and effort estimates, so teams unblock themselves before auditors ask why.

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.

Guided SDLC Workflow

IEC 62304 workflow template

IEC 62304-compliant lifecycle workflows for every software safety class (A, B, C) are built into P4SaMD and guide teams through the correct phases and required artifacts, so every team always knows what to do next and auditors always find what they expect.

Single Source of Truth

All your data, in one place

P4SaMD continuously ingests data from your connected tools and maintains a unified, live record of every requirement, risk, design output, code change, and approval — so your team always works from a single, consistent picture of the project, regardless of which tool they used to create it.

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
Related Use Cases

See it in action.

For Pre-Market Startups & Scaleups

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.

Read Use CaseFor AI-Native SaMD Enterprise

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.

Read Use CaseFor MedTech Giants & Life Sciences Enterprises

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.

Read Use Case
Pricing

Find the right plan for your team.

From your first SaMD to enterprise-scale multi-product compliance — P4SaMD grows with you.

StandardSmall teams
ProfessionalGrowing teams
UnlimitedEnterprise
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compliant software faster?

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