About medairon
Regulatory expertise, software and over 25 years of our founder's hands-on practice in regulated industries — at medairon this flows into a tool with which small manufacturers no longer have to shoulder their MDR obligations alone.
Why medairon exists
The regulatory overhead in product development eats up a disproportionately large part of the time — time that should really go into the product. Small manufacturers in particular spend more hours documenting their work than on the work itself.
For us this was not a single flash of inspiration, but a recurring insight from practice: this effort is enormous — and at the same time follows clear, firm rules. What is specified this precisely by regulations and standards can be structured and largely automated, instead of building it by hand from scratch every time.
That is exactly what software can do reliably: it applies the rules consistently and takes on the repetitive legwork, so that time is left for the decisions that truly require professional judgment. A consultant bills every hour — a rule-based tool makes the same step reproducible, and again the next time.
You make the professional decision — we make sure you can prove it at any time.
There is no anonymous software house behind medairon. What medairon is made of is what such a tool really needs: regulatory expertise along MDR and MDD, software development, end-to-end traceability and localization into eight languages — competencies you can verify in the product itself.
- Regulatory Affairs & Quality Management (MDR/MDD)
- Software development
- Traceability / audit trail
- Localization (8 languages)
The foundation for this is the hands-on practice of our founder Manfred Deinzer. He has been developing products for over 25 years, since 1997 continuously in highly regulated, safety-critical industries — a world in which a documented record is non-negotiable. Until 2017 that was safety-critical aviation electronics; since 2017 he has brought the same evidence discipline into medical technology, along MDD and MDR.
He has worked hands-on on exactly the mandatory tasks that medairon supports today: classified products, accompanied audits, accompanied conformity assessment procedures with Notified Bodies. medairon grew out of that — not on the drawing board, but out of this work.
He is at the same time the face and the point of contact. If you have a question, write to me directly: info@medairon.com
What we stand for
medairon takes the recurring documentation and evidence effort of the MDR off small manufacturers' hands — and delivers the finished mandatory document from it, instead of leaving them alone with an empty template.
What we deliberately do not promise
We expressly do not promise to take the professional decision off your hands or to guarantee conformity. medairon supports, structures and documents — the responsible decision is made by the manufacturer. What we assure is not a passed audit, but a traceably documented basis for it.
Traceability
Every step is documented: rule trace and audit trail, instead of a result that no one can reconstruct.
Honesty
We say clearly what the tool can and cannot do. Better to draw a limit openly than to make a promise that does not hold up in an audit.
Focus on the essentials
The technology takes on the tedious legwork so that your time is left for the professional judgment.
medairon documents. You decide.
We built medairon to take on the tedious legwork — structuring, documenting traceably, finishing the mandatory document. It deliberately does not make the professional decision for you. That stays with the manufacturer — where the responsibility sits.
That is not a shortcoming but by design — and to your advantage. A tool that 'took' the decision off your hands would feign a certainty that no tool can carry: in an audit, you are liable, not the software. medairon turns it around — you keep control over every professional assessment and, at the same time, have a complete, presentable record of how each one came about. You decide with authority and can prove it at any time.
The logic behind it is rule-based and traceable — the rules come directly from standards and regulations. You can trace back every step.
Who medairon is built for
medairon is built for small and young medical device manufacturers — startups and SMEs with small RA/QM teams that have to shoulder their MDR obligations without a large compliance department.
Larger manufacturers can use the tools just as well. What medairon is deliberately not aimed at is global corporate submissions or a full eQMS for design control — others are at home there. medairon focuses on the recurring mandatory tasks after market launch and on the evidence that costs small teams the most time.
You don't have to take our word for it — you can check it.
Many of our tools are free to try: try them on your own case, without risk, without a contract. On top of that come four hard points against which you can measure medairon.
Rule-based and traceable
The rules come directly from standards and regulations; you can trace back every step.
Every step in the audit trail
Who did what and when is recorded without gaps — presentable in an audit.
Finished mandatory documents
MIR, PSUR, SSCP, complaint report, signed UDI validation: you get the result, not an empty template.
In your working language
Every mandatory document in one of 8 languages (DE/FR/IT/ES/NL/PL/SV/EN).
The best way to judge is to see for yourself — on your own case, free of charge.
Or write to me directly: info@medairon.com