ipp. academy
Don't panic.
It's only the MDR.
A field guide for founders who'd rather build the product than fight the paperwork.
What it takes to reach the market — minus the panic.
Most MedTech startups don't fail for lack of templates.
They fail because everything is built separately.
It's 11 p.m. The product works. Then the email lands: the Notified Body would like your clinical evaluation by Friday. Now you're reverse-engineering documentation for decisions you made six months ago. That gap has a name — regulatory debt — and it's the slowest, most expensive way to reach the market.
Read: quality over wishful timelines →Do it yourself. Do it right.
The Easy13485 Makerspace is a QMS and regulatory operating model for MedTech startups — not a consulting program you hand your project to. It pulls product, documentation, quality and regulatory work back onto one path, so evidence is created while you build, not reconstructed in a panic afterwards. You deliver the work. We step in only when it gets critical. The result is a quality system you can open, operate and defend yourself.
Audit readiness, built in
Readiness comes from daily operation — guided workflows, templates, training and AI in the background — not from a cleanup the week before the audit.
Explore the Makerspace →The Journey turns uncertainty into a path.
Five stages, one operating model. Each stage produces real, controlled evidence — so the next one starts from solid ground.
- Claim logic & intended use
- Route & risk-class assumption
- Light, Essential or Certified
- Clinical investigation input
- Evidence & review strategy
- Role clarity for the next phase
- Controlled design & review records
- Risk, verification & validation
- Tech doc from real development
- Find the right process & template
- Scoped, source-bound first drafts
- Review stays with your team
- PMS, CAPA & management review
- Operational QMS routines
- Readiness audit & support
No full QMS commitment before the claim is understood. The Claim Check is where every Journey starts.
Walk the full Journey →From decision to CE mark — repeatedly, across device classes.
Receipts, not promises. Class I to Class IIa teams using the Makerspace have reached ISO 13485 certification and CE marking in roughly five months — with lean spend and full cost transparency.
"From the decision to go with Easy13485 to CE mark in under five months — exactly the structure we needed to start generating revenue."
"ISO 13485 certification in just five months — fast, structured and completely transparent on cost. For a Class IIa startup, that speed is crucial."
"What stood out was the structure and the full cost transparency — no surprises along the timeline. Surveillance audit: zero findings."
The Journey sells the path. Five capabilities prove it.
Each one is a system you can open, operate and defend — not a slide.
Claims, development and evidence — traceable from day one and connected to your QMS.
AI-guided access to your roles, processes and templates. Scoped to you — not generic AI.
Role-based training that turns responsibility into documented, audit-ready competence.
A maintained QMS workspace for daily operation — a working environment, not a folder.
Checks, findings and audit-oriented preparation, built through daily work.
The jokes are ours. The accountability is real.
The structure and the AI sit on two decades of regulated medical-device practice. Easy13485+ now integrates ISO 13485 and ISO/IEC 27001 into one lean system, with auditable norm mappings instead of manual claims. Review and responsibility always stay with the people accountable for the device.
From the field.
Make a choice.
This is your last chance. After this, there's no turning back — you stay in chapter one, or you start moving.
Stay where you are: endless templates, meetings and audits, the QMS always three weeks behind the product. The story loops back to 11 p.m. on a Thursday.
- Free e-learning: your 16 manufacturer obligations
- Certificate on completion + first call, free
- A self-assessment that feeds your Claim Check
- Or go direct: a 120 € / 45-min expert call
The Claim Check is the first paid step. The call is not.
No. 01 · 2026
This is the field guide. The detail lives at ipp-nbg.de.
The Journey Calculator, every capability in depth, the Fellowship and the full resource library are one click away. Bring your claim — we'll help you find the route.
academy.easy13485.com
+49 911 360 697 10
90471 Nürnberg, DE
Mon–Fri · 8:00–14:00 · Nürnberg Field Guide No. 01 · 2026
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