The finished mandatory document. Not the empty Word template.
MIR, PSUR, SSCP, signed UDI validation: medairon generates your MDR mandatory PDFs from your own data — in authority-ready format, in your language, with a full rule trail. Reporting deadlines are calculated automatically, so no notification slips through.
Covers: EU MDR · IVDR · IEC 62304 · ISO 14971 · EU AI Act
PMS suite · example output
Three ways to get started
Free tools
Classify your device, determine its standard class, find a designated notified body — with a PDF result, no sign-up; more after a free login.
Start for freePMS suite
Ongoing post-market surveillance with finished mandatory PDFs: complaints, incidents with automatic deadlines, PSUR — from your own data.
Explore the suiteStandards & knowledge
EU MDR, IEC 62304, ISO 14971 and 13485 explained clearly — look up what a standard actually requires of you.
Browse the standardsWhat you actually get
You don't download an empty template. medairon turns your data into the finished, audit-ready mandatory document — in the official format, in your language.
MIR report
PDF/A-3bReporting deadline calculated automatically (red in the dashboard when overdue) plus a finished MIR PDF in the official format — helps you not miss the deadline or the form.
PSUR
PDF/A-3bPSUR largely self-populated from your PMS data and exported as a tamper-evident PDF — days of manual aggregation in Word/Excel disappear.
SSCP
PDF/A-3bStructured SSCP following the official MDCG 2019-9 outline, with version and approval history — an EUDAMED-ready output, not a blank document.
Complaint report
PDF/A-3bFrom logged complaints, one click produces an audit-ready investigation report (PDF/A-3b) — instead of filling in Word by hand.
CAPA record
Audit trailA guided CAPA from root-cause analysis through the corrective action to the effectiveness check — with deadline display and a gap-free history. At audit you evidence the closed corrective-action loop instead of carrying an open CAPA as a finding.
Signed UDI validation
PDF/A-3bA signed, tamper-evident proof (PDF/A-3b) that your UDI label meets the requirements — presentable at audit and for EUDAMED upload.
Market surveillance as one guided process — instead of Excel, Word and a consultant.
Once your product is on the market, the MDR requires you to monitor it in the field: collect complaints, report incidents on time, spot trends and summarise all of it in periodic mandatory reports. The PMS suite brings this duty into one place — your data flows into finished, authority-ready mandatory documents instead of an empty template.
Report an incident on time
The suite calculates the reporting deadline automatically (2, 10 or 15 days depending on the case) and produces the MIR report in the official format. Overdue reports show red in the dashboard.
Produce the periodic mandatory report
Depending on device class, the suite produces the PSUR (Class IIa and up, MDR Art. 86) or the PMS report (Class I, MDR Art. 85). The applicable document largely self-populates from your complaint, incident and trend data and is exported as a tamper-evident PDF — days of manual aggregation in Word and Excel disappear.
Close out CAPA properly
A guided flow from root-cause analysis through the action to the effectiveness check, with deadline display. No dragged-out CAPA that turns into an audit finding.
Spot clusters early (trend)
The dashboard shows which report is due next and whether a trend under MDR Art. 88 is emerging — before single complaints become a reportable pattern.
- Create & edit
- Release (Released)
- All modules & tools
MIR report
PDF/A-3bReporting deadline calculated automatically (red in the dashboard when overdue) plus a finished MIR PDF in the official format — helps you not miss the deadline or the form.
PSUR
PDF/A-3bPSUR largely self-populated from your PMS data and exported as a tamper-evident PDF — days of manual aggregation in Word/Excel disappear.
CAPA record
Audit trailA guided CAPA from root-cause analysis through the corrective action to the effectiveness check — with deadline display and a gap-free history. At audit you evidence the closed corrective-action loop instead of carrying an open CAPA as a finding.
PMS €80/mo on top of Pro €99/mo = €179/mo · plus VAT, −25% annually
When your medical-device app goes to the app store.
A medical-device app listed on Apple or Google has to meet more mandatory information than an ordinary app: the relevant mandatory details (incl. MDR, DSA, eIFU) must be correct and evidenced in the listing. The module guides you through exactly these details and bundles them into a dated compliance dossier — a presentable record you would otherwise assemble by hand from several sources.
Collect mandatory details in one place
Capture MDR, DSA and eIFU details for your listing in a guided way — instead of laying regulation texts side by side and guessing what belongs in the store listing.
Make the record presentable
The result is a dated compliance dossier as a PDF — ready for internal sign-off, an audit or a query from the store operator.
Keep it current when rules change
Listing duties change. Ongoing maintenance keeps your dossier tended instead of letting it go stale after the first build.
Compliance dossier
PDFA dated compliance dossier as a PDF documenting your store listing's mandatory details in one place — presentable for sign-off, audit or a store query.
Setup pack €490 one-time · maintenance €29/mo · requires an active Pro account · plus VAT
The working layer for the regulatory tasks before market launch.
Pro is the entry tier: classify a product, determine the software safety class, assess risk and QMS gaps, find the right notified body, validate UDI labels — unlimited, with saving, PDF export and an audit trail. The free tools answer a single question; Pro turns that into ongoing, documented work with saved sessions instead of throwaway results.
Classify defensibly — with proof
Device class, IEC 62304 safety class, risk and QMS assessment with a traceable rule trail and PDF — reproducible if an auditor asks later.
Keep your work instead of throwing it away
Save sessions, export as PDF, record them in the audit trail with a hash chain. Free loses every result on close — Pro does not.
Validate UDI labels before it gets expensive
Up to 50 signed UDI validations a month — a presentable proof that your label meets the requirements before it goes to print or EUDAMED.
- Create & edit
- Release (Released)
- All modules & tools
Classification report
PDF/A-3bDevice class and safety class with a traceable rule trail as a PDF — reproducible if an auditor asks.
Signed UDI validation
PDF/A-3bA signed, tamper-evident proof that your UDI label meets the requirements — presentable at audit and for EUDAMED upload.
€99/mo · 1 full seat incl. · more seats from €29/mo · plus VAT, −25% annually
Free tools
3 analyses without an account · 10 per day with a free account · Pro unlimited.
Qualification Navigator
Is your product a medical device? Determine the device class.
Use toolNotified Body Navigator
Find the right Notified Body for your medical device
Use toolEUDAMED Navigator
Understand and prepare for EUDAMED obligations
Use toolMDR Classifier
Determine your medical device class (I / IIa / IIb / III) under EU MDR Annex VIII.
Use toolISO 14971 Risk Matrix
Estimate initial and residual risk (severity × probability) and get your risk acceptability decision per ISO 14971:2019.
Use toolISO 13485 Gap Checker
Assess your QMS against all key ISO 13485:2016 clauses, identify gaps, and get a prioritised remediation plan.
Use toolIEC 62304 Classifier
Classify your software safety class (A / B / C) and get the mandatory document checklist.
Use toolAI Act Classifier
Classify your AI system under the EU AI Act and get a full conformity assessment gap report with prioritised actions.
Use toolWhy medairon
Rule-based, no AI hallucination
Results follow the rules from regulation and standard — traceable and reproducible, without generative AI.
Audit trail with roles
Gap-free hash chain with approval roles (Reviewed · Approved · Released) — ISO 13485-ready, prepared for 21 CFR Part 11.
Data in the EU
Hosting on European servers. GDPR-compliant, no transfer to third countries.
8 languages, country-specific
Interface and documents in 8 languages — with templates, authorities and deadlines per target market.
Regulations & guides
Standards, regulations, directives and laws at a glance
EU MDR 2017/745
Classification, conformity assessment, technical documentation, clinical evaluation, and post-market surveillance under the EU Medical Device Regulation.
Read guideIEC 62304
Software lifecycle requirements for medical device software — safety classification, documentation, and verification for embedded and SaMD.
Read guideISO 14971
Risk management for medical devices — hazard identification, risk estimation, risk controls, and residual risk evaluation.
Read guideISO 13485
Quality management systems for medical devices — the QMS standard required for CE marking and FDA registration.
Read guideIEC 81001-5-1
Cybersecurity activities in the health software product lifecycle — harmonised with EU MDR GSPR 17.
Read guideEU AI Act
Compliance requirements for AI-enabled medical devices under the EU AI Act — risk classification, technical documentation, and conformity assessment.
Read guideStay ahead of the regulations
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