medaironcompliance.engineered

pricing

One plan that grows with you.

Start free, go Pro for the work before launch, add the PMS suite for the duties after.

All prices are net and exclude statutory VAT. This offer is aimed exclusively at businesses within the meaning of § 14 BGB, based in the EU.

The following apply: Terms and Conditions · Data Processing Agreement

No account
Just looking
0 €
3 analyses with all base tools
No sign-up needed
No saving, no PDF
Open a tool
Free account
Test regularly
0 €
10 analyses per day
1 demo UDI label (watermarked)
No saving · PDF as watermarked preview only
Create account
Pro
Recommended
Active RA work
99€/mo
All tools, unlimited
Saving + PDF without watermark, with document ID and date
Audit trail: UDI validations as a hash chain
UDI validator 50/mo · 3 full seats incl. PRRC
Add a full seat
0

Pro includes 3 full seats. Further seats for €29/mo each.

Pro + PMS suite
The duties after launch
179€/mo
= Pro €99 + suite €80
Everything in Pro, plus the recurring part of the MDR:
Complaint · Incident with deadline and decision record · Trend
PSUR · CAPA · SSCP · FSCA routing for 33 markets
Unlimited UDI validations
Team & roles

For collaborating on PMS deliverables (PSUR, vigilance, FSCA). Pro already includes 3 full seats, the owner with PRRC among them.

Full seat29 €/mo

Run tools, sessions, approvals. With PRRC flag: released rights.

Monthly plan cancellable anytimeAnnual plan ends at termPayment via Stripe · GDPR, data in the EU
Can I cancel monthly?
Yes — the monthly plan can be cancelled anytime and ends at the end of the month. The annual plan runs until the end of its term. You manage everything yourself in your account (Stripe portal).
When do I need the PMS suite?
As soon as a product is on the market. That is when the duties begin that never stop: recording complaints, reporting incidents within 2, 10 or 15 days of becoming aware, submitting a periodic safety update report every one to two years depending on class. Pro covers the work before; the suite covers the operation after — €80/month on top, cancellable monthly.
What does the free account cost?
Permanently free, no credit card. 10 analyses per day (vs. 3 without an account), 1 demo UDI label, and every result as a watermarked preview PDF. Saving and the document without watermark are Pro.
What are the seats for?
There's one seat type: the full seat. It runs the tools and it approves or rejects the result — the whole cycle, with PRRC marking. Pro comes with 3 full seats; further seats cost €29/mo each (€261 per year).

app-store-compliance

Listed cleanly, once — with proof, not gut feeling.

The Setup-Pack (€490 one-time) gets you cleanly into the app-store listing once; the Maintenance-Abo (€29/mo) keeps that state defensible when releases and mandatory data move; the Stack (€159/mo) is for anyone who wants to run the full post-market duty mechanics from one system.

Set up once. Kept in step at every release.

Stage 1 — Setup Pack: gets you set up.

Brings your conformity data to the right state — UDI-DI, EUDAMED, eIFU, listing data, configured cleanly, once.

Stage 2 — Maintenance subscription: keeps it in step.

Any significant change can trigger downstream obligations — the subscription covers the ongoing assessment and upkeep, release after release.

Setup gets you to the start line. Maintenance keeps you ready at the trigger — every time a release or data change kicks something off.

Setup-Pack
Entry
First-time compliance · per app + platform
490€ one-time
The right mandatory data in the right place — at the listing. Pulls your UDI-DI, EUDAMED and listing details together so the required manufacturer information is complete and consistent at listing time. (Mandatory source: MDR Annex VI; platform listing-data requirement: DSA Art. 30(1).)
Distinct-category documented instead of freely interpreted. Helps you record the details required for the product category in a structured way — the "recommended" proof at listing, documented in case of a query. (Distinct-category verification = listing time / "recommended", not an ongoing duty.)
A presentable state instead of a law-firm memo to look up. You get your listing conformity as a documented state you can show in an audit or a platform query. (Comparison to a €5–15k law-firm memo: [hypothesis], not a hard comparative fact.)
Maintenance-Abooptional add-on
€29/mo · event-driven, not calendar-based

Compliance is not a one-off. Maintenance keeps your conformity data ready at every release.

29€/mo
A clear UDI-DI check at every release. You check, guided, whether the change is significant (→ new UDI-DI) or a bug fix / patch (→ only a new UDI-PI). No automatism per release — only when the change actually triggers it. (Mandatory source: MDR Annex VI Part C §6.5.2; Art. 13/14.)
EUDAMED, eIFU and listing data stay at the product state. When something on the product changes, you carry the stored mandatory data forward — revisions of your instructions for use stay labelled and available in versioned form, so the listed state matches your actual state. (Mandatory source: MDR Annex VI; eIFU versioning/history: Implementing Regulation (EU) 2021/2226 Art. 5(8)/(13), 7(2)(f).)
Data gap = risk — before it becomes a problem. Outdated or incomplete listing data can lead to a suspension risk — the platform can suspend the availability of your offering until the data is corrected. Maintenance keeps you able to act at the trigger. (Risk source: DSA Art. 30(3) — "inaccurate, incomplete or not up to date" → platform "shall swiftly suspend". Platform mechanism, not a direct manufacturer duty.)

No expiry clock: you pay for the upkeep your release cadence keeps generating, not for an approval that runs out. Maintenance walks you through the assessment and helps you carry the change through — the significant-change decision you document in your QMS.

What this pack does — and what it doesn't

What it does:

  • Sets up your app-store compliance folder once and puts your DSA trader data and eIFU records in their place.
  • Shows you honestly which mandatory entries are present and which you still need to add.
  • Gives you a dated, traceable folder for step 1 of your listing.

What it does NOT do:

  • It does not keep your folder up to date automatically. If your product, your eIFU or your trader data change, the folder does not update itself — that ongoing upkeep is handled by the Maintenance-Abo.
  • It does not replace legal or regulatory advice and makes no conformity decision for you.
  • It does not submit anything to Apple, Google or any authority — submission stays with you.

In short: this pack gets you cleanly to the starting line. Keeping it current is a separate, ongoing step.

Payment via Stripe · GDPR, data in the EUMandatory sources: MDR Annex VI · DSA Art. 30 · Implementing Regulation (EU) 2021/2226

All prices are net and exclude statutory VAT. This offer is aimed exclusively at businesses within the meaning of § 14 BGB, based in the EU.

The following apply: Terms and Conditions · Data Processing Agreement