P4SaMD — The compliance platform for Software as a Medical Device.
Mia-Care builds P4SaMD (Platform for Software as a Medical Device) — an end-to-end compliance orchestration platform that lets engineering teams build, certify, and maintain regulated medical software without sacrificing development velocity.
Traditional SaMD development treats compliance as a phase that happens after engineering. P4SaMD makes it a continuous, automatic output of the way your team already works — from the first commit to the final submission package.
| # | Capability | What it does |
|---|---|---|
| 01 | SDLC Workflow Orchestrator | Connects Git, ALM, and eQMS into a single IEC 62304-compliant workflow. No rip-and-replace. |
| 02 | Automated Real-time Traceability (ARTT) | Maps every requirement, risk, code commit, and test automatically. The traceability matrix is always current. |
| 03 | Documentation Engine | Continuously assembles DHF, Technical Files, and audit packages from live development data. |
| 04 | Smart Assistant (Whisper) | In-workflow regulatory intelligence aligned with MDR, IEC 62304, FDA, and EU AI Act. |
| 05 | Master AI for Compliance | EU AI Act Annex IV, GMLP, and FDA PCCP enforcement for AI-enabled SaMD — audit records, bias reports, and PCCP change control built in. |
| 06 | Brownfield Remediator | Ingests any legacy estate, runs automated gap analysis, and generates a prioritized remediation task list. |
| 07 | Secure Software Development | Continuous SBOM management, CVE scanning, and IEC 81001-5-1 guardrails embedded in the development toolchain. |
| 08 | Guided Workflows | Step-by-step compliance guardrails for every developer — no deep regulatory expertise required. |
Build a SaMD from scratch with compliance from the first line of code. Eliminate the 3–6 month documentation sprint before launch. One digital health startup went from zero to a fully compliant MVP in 1 month, with zero manual traceability effort.
Ship AI-enabled clinical software across MDR + EU AI Act + GMLP from a single platform. Automated model cards, bias assessments, and PCCP change control mean model updates never block a release. Customers have achieved 50% reduction in time-to-compliance for new AI feature releases.
Turn regulatory debt into a structured certification path without rebuilding. P4SaMD ingests existing codebases in any language, reconstructs traceability via ARTT, and generates audit-ready documentation. Results include 60% reduction in remediation effort and 90% reduction in Technical File generation time.
IEC 62304 · ISO 13485 · EU MDR 2017/745 · ISO 14971
FDA 21 CFR Part 820 · IEC 81001-5-1 · EU AI Act · GMLP · PCCP
| Layer | Technology |
|---|---|
| Framework | Next.js 16 (App Router, static export) |
| UI | React 19, Tailwind CSS v4, shadcn/ui |
| Language | TypeScript |
| Linting / Formatting | Biome |
| Deployment | GitHub Pages (via GitHub Actions) |
# Install dependencies
npm install
# Start dev server
npm run devOpen http://localhost:3000/website.
# Type-check
npm run type-check
# Lint
npm run lint
# Format
npm run formatEvery push to main triggers the deploy workflow:
push to main → next build → upload out/ → deploy to GitHub Pages
Live at: https://mia-care.github.io/website/
The site is a fully static export (output: 'export'). No server required.
app/ # Next.js App Router pages
page.tsx # Homepage (/)
(marketing)/ # Conversion pages — pricing, request-demo
(platform)/ # Product pages — product, capabilities/[slug], use-cases/[slug]
(company)/ # Company pages — about-us, careers, newsroom, certifications, sustainability
(resources)/ # Knowledge hub — blog, competence-center, docs, events, faq
(legal)/ # Legal — privacy-policy, cookie-policy
components/
layout/ # Global shell — Navbar, Footer, MobileMenu
common/ # Reusable across 2+ pages — CtaBanner, ComplianceStrip, PillTag…
sections/ # Page-specific sections
home/ # Homepage sections — HeroBanner, StatsRow, ProblemSection…
capability/ # Capability detail — CapabilityHero, FeatureCards…
use-case/ # Use-case detail — UseCaseHero, CaseStudyBlock…
ui/ # shadcn/ui primitives — button, card, badge…
data/ # TypeScript content files — capabilities, use-cases, nav, site
lib/ # Utility functions
public/ # Static assets (fonts, images, robots.txt)
docs/
content/ # Copy and information architecture
design/ # Visual identity, branding, Styrene fonts
specs/ # Technical and feature specifications
Copyright © Mia-Care. See LICENSE.