BLCK. 00MAKERSPACE OPERATING MODEL
Easy13485 Makerspace

Easy13485Makerspace

The QMS & Regulatory Operating Model for MedTech startups — so teams keep building while regulatory structure, evidence and audit readiness grow underneath.

Start Claim CheckSee the Lifecycle
Easy13485 Makerspace frog mascot
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BLCK. 01OPERATING MODEL
What the Makerspace is

A guided regulatory operating model for MedTech startups.

The Easy13485 Makerspace is not a consulting program and not a template library. It gives startup teams a structured way to build their product while regulatory evidence, QMS logic and audit readiness grow in parallel.

The journey starts with the Claim Check. Only then does the team move into the right pathway and the product lifecycle.

Start with Claim CheckSee the Pathway

Five capabilities. One journey.

Evidence, Easy Expert, Academy, QMSaaS and Readiness Audit & Audit Support are introduced as the lifecycle needs them.

BLCK. 02ENTRY GATE
Entry Gate

First we assess. Then we guide.

The Claim Check turns early uncertainty into regulatory direction before the startup commits to QMS depth, audit route or unnecessary complexity.

01Claim logicWhat does the product promise, and can that claim survive review?
02RouteWhich MDR route, intended use and risk-class assumption are plausible?
03Team readinessWhich roles, gaps and responsibilities must be visible before scaling?
04Pathway fitThe outcome is a recommendation for Light, Essential or Certified.

Outcome: a clear next step - not a pile of obligations.

Continue to Pathway
BLCK. 03PATHWAY DEPTH
Pathway after Assessment
Recommended / 03

The right depth. At the right time.

The pathway defines how much regulatory structure the startup needs after the Claim Check.

Recommended after Claim Check

Essential Pathway

Class I / Class IIa

For teams that need MDR-compliant development, structured evidence and guided QMS adoption without jumping into full certification pressure too early.

What this pathway gives the team
01Regulatory foundationClaim logic and development planning embedded into daily work.
02Evidence while buildingDesign inputs, risk logic and verification grow with the product.
03Guided maturityMore regulatory depth only when the lifecycle needs it.

No package logic before route logic. First the claim is understood. Then the pathway defines the level of structure.

Continue to Lifecycle
BLCK. 04PRODUCT LIFECYCLE
PLC Journey
Step 01 / 04

Explore & Plan

Set the product direction before documentation debt starts.

Regulatory phase detail

Claim, intended use and route.

This phase keeps the team from building on assumptions. It translates the early product idea into a regulatory direction that can be used for planning, design input and later evidence.

What this phase covers
  • Clarify intended use, product claim and the first regulatory route before the team creates documentation debt.
  • Connect product ambition with MDR plausibility, risk class assumptions and the first controlled design inputs.
RelevanceAvoids building on an unclear claim or route.
ScopeIntended use, claim logic, route and first design inputs.
MaturityProduct direction becomes regulatory plausible.
BLCK. 05SCOPE EXTENSIONS
Extensions

More scope only when the product needs it.

The Makerspace stays focused at the core. Additional modules are introduced only when product complexity, team growth or regulatory route make them necessary — never as a default add-on.

01

Team Expansion

Role-based access and responsibilities scale as the team grows into the QMS.

02

NB Support

Structured handling of Notified Body interaction and audit communication.

03

Scope Extensions

Context-specific modules — added only when product scope or regulatory route requires them.

BLCK. 06AGUIDANCE LAYER
AI Navigator

AI guides.

Easy Expert helps teams find the next step inside the controlled QMS.

Guided by the QMS.The AI follows the curated Easy13485 structure. It does not invent the regulatory route.
Learn about AI ExpertsBack to Lifecycle
BLCK. 06BASSURANCE LAYER
Human Assurance

Experts control.

IPP professionals keep claim, route and audit confidence under human responsibility.

Human judgment stays in control.Claim Check, pathway decisions and critical reviews remain expert-led.
Meet our professionalsStart Claim Check
BLCK. 07CURATED ENTRY
Fellowship Program

A curated entry path for startups IPP believes in.

Fellowship is not a discount. It is selective Makerspace access for teams with strong product potential and the discipline to build regulatory structure early.

Request Fellowship ReviewStart Claim Check
BLCK. 08 SYSTEM CAPABILITIES
Capabilities

The five capabilities behind the Easy13485 Journey.

The Journey sells. The capabilities prove. Each capability supports the path from first claim to operated QMS and audit readiness.

Capabilities
Easy13485 Journey

📄

Evidence

Claims, development and evidence — traceable from day one.

💻

Easy Expert

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

🎓

Academy

Role-based training with documented competence.

⚙️

QMSaaS

A maintained QMS workspace for daily operation.

🧾

Readiness Audit

Checks, findings and audit-oriented preparation

ipp.

Contact

  • Kerschensteinerstr. 79
    90471 Nürnberg
  • kontakt(at)ipp-nbg.com

Office hours

Monday to Friday
8:00 am - 2:00 pm