Easy13485 Makerspace · MedTech startups & SMEs

Build the product. Keep the path clear.

A QMS-/Regulatory Operating Model that helps teams clarify the claim, choose a plausible route and build evidence without turning early product work into regulatory debt.

Before the Journey

The Journey turns uncertainty into a path.

Once the Makerspace gives the operating model, the Journey shows how a team moves through it: from claim clarity to planning, evidence, automation and operated QMS practice.

Enter the Journey

Easy13485 Journey

Stage 01 / 05
‹

Claim Check

First, know what you are.

›

Easy13485 Journey

Stage 02 / 05
‹

Explore & Plan

Plan the route before regulatory debt starts.

›

Easy13485 Journey

Stage 03 / 05
‹

Build, Verify & Document

Work like engineers & build MDR-ready evidence.

›

Easy13485 Journey

Stage 04 / 05
‹

Automate

Your QMS answers back. Ask what applies, who owns it, draft it – inside your scope.

›

Easy13485 Journey

Stage 05 / 05
‹

Operate & Scale

What starts as guidance becomes operation.

›

Next right step

Start with the Claim Check.

The Claim Check shows where the team stands, which route is plausible and which product line fits. No full QMS commitment before the claim is understood.

Request Claim Check

Capabilities

The five capabilities behind the Journey.

The Journey sells the path. The capabilities prove it. Each one is a system you can open, operate and defend.

Evidence

Evidence & Technical Documentation

Claims, development and evidence — traceable from day one.

 Easy Expert

Easy Expert

AI-guided access to Easy13485 roles, processes and templates.

 Academy

Academy & Role Training

Role-based training with documented competence.

 QMSaaS

QMSaaS

A maintained QMS workspace for daily operation.

 Readiness Audit

Readiness Audit & Audit Support

Checks, findings and audit-oriented preparation.
For ambitious MedTech startups
Fellowship Selective Partnership Program

For startups ready to build their QMS with us.

The Easy13485 Fellowship is for selected MedTech startups that are serious about working closely with IPP — and want to benefit from a trusted, long-term partnership while building an audit-ready QMS stage by stage.

Exclusive access by application Close IPP guidance throughout your journey Virtual stage budget of up to 37,500 €
Built on trust: The Fellowship is not a discount program. It is designed for startups willing to collaborate actively, share feedback and enter a genuine partnership with IPP.
Explore the Fellowship Limited availability · For selected startups only
Ted — Easy13485 Mascot
Get ready

Get ready.
Then let's talk.

Two steps before the call. About 30 minutes. Then we can focus on your situation — not on basics.

Step 1 · ~20 min

Watch the 16 Legal Duties

  • 1 16 short videos — 30 seconds each. What you're responsible for as a medical device manufacturer.
  • 2 Read additional context as needed — 10 to 60 minutes, depending on where you are.
  • 3 Fill in the self-assessment — 10 minutes. Gives us a head start before the call.
Start the free module →
Step 2 · 45 min

Book a call

Once you've worked through the module: book a 45-minute call. We'll go through your situation and agree on whether a Claim Check is the right next step.

Book a 45-min call →

The Claim Check is the first paid step. This call is not.

Selective access · Easy13485 Fellowship
up to 30,000 €
virtual stage budget behind the few teams we believe in

Not for everyone. Prove you're tough enough.

Most MedTech startups never make it past application. The ones who do get more than a budget — they get IPP's own team behind their build.

01
Selected, not self-served
Application and review — not for everyone who asks.
02
A signal investors recognize
Being chosen by IPP is a due-diligence signal on its own.
03
Real IPP budget on the line
Skin in the game — not a discount, not a freebie.
Apply now →
Ted — Easy13485 Mascot
"If the Fellowship had existed for me, this would be one page — and a lot less funny."
Ted