EU MDR 2017/745 · ISO 13485
AI-native regulatory consulting for medtech.
With focus on SaMD, SiMD, and AI-enabled devices.
We pair hands-on regulatory experience with technical and AI expertise, so the hard judgment gets expert attention and the document work goes faster.
What we do
EU MDR regulatory consulting for software and AI medical devices.
Hands-on regulatory work, not just advice.
We write the content and structure your technical files ourselves. Senior, and scoped to where you are now.
Objective gap analysis
An independent read of where you stand against MDR and ISO 13485, with the gaps ranked by what matters. The place to start.
SaMD classification and regulatory strategy
A defensible classification and a clear route to market, before you commit to building it.
ISO 13485 quality management system
An ISO 13485 quality system sized to your stage and shaped to how your team actually works, not a binder that fails its first audit.
MDR technical documentation (Annex II and III)
The full technical file a Notified Body expects, pre-market and post-market, shaped to fit how your team already builds.
Clinical evaluation for software devices
A realistic evidence plan: what you need, what you can defer, and which studies you can avoid.
Post-market surveillance and vigilance
Surveillance, incident tracking and periodic reporting, set up once rather than rebuilt each year.
Pre-market to post-market. One senior team.
Who we serve
SaMD, SiMD, and AI-enabled devices.
Software that is the device, software inside the device, and the AI models inside them. All three are our core work.
Software as a medical device (SaMD)
Standalone software performing a medical function on its own: diagnosis, triage, monitoring, treatment planning. Classified under MDR Rule 11.
Software in a medical device (SiMD)
An algorithm embedded in hardware, where the device is classified as a whole. The model is the novelty; the hardware delivers it.
AI and ML-enabled devices
Trained models in either shape, where validation, data quality, drift, and the EU AI Act sit on top of MDR.
If the core of your device is an algorithm, you are in scope.
Why Artifakt
SaMD and AI device specialists, not generalist consultants.
We focus on the detail.
We go deep, not wide
We take on a small number of partners and stay with them, rather than spreading thin across many clients and letting quality slip.
Specialists only
Software and AI medical devices are all we do. We understand the product and the regulation at the same time.
We work to your timeline
Paced to your roadmap and your raise, clearing the next milestone instead of becoming the bottleneck.
Every output peer-reviewed
A second specialist checks the work before it reaches you.
Where we're going
Consulting today, automation next.
Alongside the consulting, we're building AI automation for the same work, aimed at significantly reducing the cost and timelines of getting and staying compliant. We're early, and the manufacturers we partner with now help shape it and are the first to benefit as it matures.
The Problem
Compliance is fragmented, static, and manual.
01
Fragmented
Compliance lives across binders, spreadsheets, and disconnected QMS tools that don't speak to each other.
02
Static
Technical documentation is treated as a one-time submission. Regulation isn't.
03
Manual
Every regulatory update means human chasing across teams, suppliers, and notified bodies.
The Thesis
Regulation is continuous. Compliance should be too.
First Module Live
ARTIFAKT VIGILANCE.
Our live, free tool for EU MDR post-market work. It aggregates eight safety databases in one query, then drafts the literature and clinical sections of your PSUR, PMCF, SSCP, or literature review to the MDCG and MEDDEV templates notified bodies expect. You review, edit, and own the final document.
Four report templates, eight safety databases, one workspace.
PSUR (MDCG 2022-21) · PMCF (MDCG 2020-8) · SSCP (MDCG 2019-9) · PRISMA / MEDDEV 2.7/1 literature review
FDA MAUDE · FDA Recalls · BfArM · MHRA · Health Canada · PubMed · Europe PMC · ClinicalTrials.gov
Try Vigilance, free
Start here
Start with a gap analysis.
A clear, honest read on where you stand against MDR and ISO 13485, and a low-commitment way to see how we work. From there, we go as deep as you need.