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Mia-Care P4SaMD
03 — DOCS

Documentation Engine

Your audit package, assembled automatically.

P4SaMD automatically generates Technical File, DHF records, risk evidence, verification reports, audit trails, and submission-ready documentation, ensuring constant audit readiness from the first commit to the final release.

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What It Does

Documentation that writes itself, from your work.

The Documentation Engine lets your SaMD team focus on what they do best: building great software. By connecting directly to your SDLC tools and pulling live development data in real time, it compiles the Technical File, Design History File, and all required regulatory evidence continuously and automatically, in your own templates, using your terminology, ready for submission at any point in the development cycle.

In Action
Dashboard
Documentation
Document Catalog
Document Detail
Custom Templates
Variable Library
Mia-Care Dev›App Cardio-Monitor›Document Catalog
Documentation
eQMS-compliant document catalog — generate, download, and manage your Technical Documentation File
↓ Export (ZIP)
Total Documents
32
Current
14
Draft
8
Needs Update
2
Not Generated
8
From Templates
3
Search by title, code, or standard…
Filters
Design & Development
Code
Document
Status
Ver.
Last Updated
Formats

Document catalog — all DHF records grouped by category, with live status, version tracking, and one-click export across PDF, DOCX, and MD formats.

Key Features
Technical File & DHF

Continuous Technical File and DHF compilation

The Technical File and DHF are compiled continuously from live development data — requirements, risks, design, implementation, and verification — so both documents always reflect the current system state.

Technical File Generation

Submission-ready EU MDR Technical Files

Produces regulation submission-ready technical files using your own templates and branding, covering all requirements automatically from structured platform data.

Release Notes

Compliant release notes, automatically

Every release automatically generates the full documentation package: SRS, Test Reports, Risk Management Files, and Traceability Matrix, complete with change log, impact assessment, and verification summary.

Audit Trail

Immutable record of every decision and change

A timestamped, tamper-evident log of every decision, change, and approval across the entire SDLC, answering 'who decided what, and when?' instantly, for any point in the product's lifecycle.

Standards Addressed

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

ISO 13485EU MDR 2017/745FDA21 CFR Part 820IEC 62304
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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Ready to ship
compliant software faster?

See how P4SaMD fits into your development workflow.

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