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Mia-Care P4SaMD
01 — SDLC

SDLC Workflow Orchestrator

One platform. Every tool. One source of truth.

Connects Git repositories, ALM, eQMS, and your Internal Developer Platform into a single unified workspace. No rip-and-replace. 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 for code, Jira for tasks, ALMs for specifications, 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, approval, and artifact captured in one place, always in sync. IEC 62304-compliant workflow structure built in, without disrupting how 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 in one view. Blocking tasks surfaced automatically with severity and effort estimates, so teams stay ahead of audits.

Key Features
Tool Orchestration

Connect without migrating

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

Guided SDLC Workflow

IEC 62304 workflow template

Built-in IEC 62304-compliant workflows for every safety class (A, B, C) guide teams through the correct phases and required artifacts. Every team knows what to do next. 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 live record of every requirement, risk, design output, code change, and approval. One consistent picture of the project, regardless of which tool created it.

Seamless Integration

No rip-and-replace

P4SaMD works alongside your existing tool stack with lightweight connectors. No forced migrations, no retraining, no disruption to 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

Regulatory debt is locking your legacy software. P4SaMD clears the 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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