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
Result on screen right away, as a preview PDF after a free login.
Start for freePMS suite
After launch: record complaints, decide incidents with a calculated deadline, see trends, close CAPAs, PSUR and SSCP as PDF/A-3b — from one body of data that grows with every case.
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 end up with
You don't download an empty template. medairon turns your data into the document that is needed in the end — PSUR, complaint report and SSCP as PDF/A-3b, the incident as a documented reportability decision.
Incident PDF
PDF/A-3bReporting deadline calculated automatically (red in the dashboard when overdue), plus an incident PDF that records the awareness date, your reportability decision and the rationale behind it. You file the report itself using the competent authority's own form.
PSUR
PDF/A-3bPSUR largely self-populated from your PMS data, as a PDF carrying a document ID and audit reference back to the underlying record — days of manual aggregation in Word/Excel disappear.
SSCP
PDF/A-3bStructured SSCP under MDR Art. 32 with version state and approval record — a document with a history, not a blank document.
Complaint report
PDF/A-3bFrom logged complaints, one click produces an investigation report as PDF/A-3b with a document ID — 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 a deadline field and a dated history. The closed loop is documented, not asserted.
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.
The duties that never stop — in one place instead of Excel, Word and consultant emails.
Once your product is on the market, the recurring part of the MDR begins: record and assess complaints, report serious incidents within 2, 10 or 15 days of becoming aware, watch for clusters, close out corrective actions, and depending on class submit a periodic safety update report every one to two years. The PMS suite runs those duties as one flow: record, decide, document, report. What you record once is already in the next report.
Complaint → Incident → Reportability decision → Trend → CAPA → PSUR → SSCP
Report an incident on time
The suite calculates the reporting deadline automatically (2, 10 or 15 days depending on the case) and records your reportability decision, with its rationale, in an incident PDF. Overdue reports show red in the dashboard. You file the report itself using the competent authority's own form.
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 PDF that carries a document ID and audit reference, so the export stays traceable to the record it came from — days of manual aggregation in Word and Excel disappear.
Close out CAPA
A guided flow from root-cause analysis through the action to the effectiveness check, with a deadline field. The closed loop sits dated in the history — instead of in three emails and one spreadsheet row.
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
Incident PDF
PDF/A-3bReporting deadline calculated automatically (red in the dashboard when overdue), plus an incident PDF that records the awareness date, your reportability decision and the rationale behind it. You file the report itself using the competent authority's own form.
PSUR
PDF/A-3bPSUR largely self-populated from your PMS data, as a PDF carrying a document ID and audit reference back to the underlying record — 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 a deadline field and a dated history. The closed loop is documented, not asserted.
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 — with no daily or monthly cap, with saved sessions and a PDF without watermark, carrying document ID and date. Plus up to 50 UDI label checks a month, each one signed and written into a continuous hash chain. The free tools answer a single question; Pro turns that into ongoing, documented work with saved sessions instead of throwaway results.
Keep your work instead of throwing it away
Save sessions, export them as PDF, open them again later. 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
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 · 3 full seats incl. · reviewers free & unlimited · additional seats from 29 €/mo · excl. VAT, −25% annually
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
Free tools
3 analyses without an account · 10 per day with a free account · Pro unlimited.
Why medairon
Rule-based, no AI hallucination
Results follow the rules from regulation and standard — traceable and reproducible, without generative AI.
Tamper-evident UDI check history
Every UDI validation is logged in a gap-free hash chain — later changes show up. Timestamp, user and result stay traceable and support your ISO 13485 record-keeping.
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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