ipp. academy
What could possibly go wrong?
Risk analysis for founders who'd rather meet the failure on paper than in production.
Everything that can go wrong — and how to catch it early.
Risk analysis isn't a document you write the night before the audit.
Everyone tries it once.
You know the pattern. An FMEA copied from a template that never quite matched the device. Hazards with no traceable controls. A risk file that froze at CE while the product kept shipping changes. Production and field data that never loop back. By audit day the risk management file reads like fiction — and Notified Bodies have read a lot of fiction.
Read: the MedTech de-risking view →Risk, as a process — not a PDF.
In the Makerspace, risk management lives in your QMS as a running process, created along the product life cycle — not bolted on at the end. Hazards, controls and their verification stay traceable to design inputs and V&V. And because risk doesn't stop at CE, production and post-production data feed back through PMS, CAPA and management review.
Traceable, not retrofitted
Hazards link to design inputs, risk controls and the verification that proves they work — captured as you build.
Evidence & Tech Doc → 02 · Easy ExpertDrafted in your scope
AI helps you find the right risk process and draft records — source-bound to your device. Review stays with your team.
Easy Expert (AI) → 03 · QMSaaSAlive after CE
Production and field signals loop back into the risk file through PMS, CAPA and management review — automatically prompted.
QMSaaS →Where the hazards actually get caught.
Risk isn't a stage — it runs through all five. Here's where each piece of the risk file is born.
- Intended use & claim logic
- Risk-class assumption
- Light, Essential or Certified
- Evidence & risk strategy
- First hazard identification
- Role clarity for the phase
- Hazard & control records
- Verification of effectiveness
- Risk file from real work
- Find the right risk process
- Source-bound first drafts
- Review stays with your team
- PMS & post-production input
- CAPA & management review
- Readiness audit & support
The risk file isn't one document — it's the trail your five stages leave behind.
Walk the full Journey →RiskMagic™ 3000
The world's first spray-on compliance.
- ✓ Generates a complete ISO 14971 risk file in 4 seconds!
- ✓ Reduces residual risk to absolute ZERO*!
- ✓ Audit-proof — as endorsed by no Notified Body, ever!
- ✓ Just spray, shake, and certify!™
*Residual risk cannot be sprayed away. Risk management is a lifecycle process under ISO 14971 and the MDR. RiskMagic™ 3000 does not exist, will never exist, and must not be used on a real medical device, a real audit, or a real human. Side effects of believing in shortcuts include findings, delays and very tired founders.
There's no spray. There's a clear first step.
Risk you can defend isn't bought in a can — it's built from a clear claim, traced through development, and kept alive after CE. That starts with a Claim Check: your risk class, your route, no full QMS commitment up front.
Proof from the field — and the tools behind it.
A few things worth the click.
Find the failure first.
The Claim Check sets your risk class and a plausible route — so risk work starts in the right place, not at 2 a.m. No full QMS commitment before the claim is clear.
The Claim Check is the first paid step. The call is not.
No. 02 · Risk Analysis · 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, and the risks worth catching first.
academy.easy13485.com
+49 911 360 697 10
90471 Nürnberg, DE
Mon–Fri · 8:00–14:00 · Nürnberg Field Guide No. 02 · 2026
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