Easy13485 Makerspace · MedTech startups & SMEs
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
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.
Next right step
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.
Claims, development and evidence — traceable from day one.
AI-supported access to Easy13485 roles, processes and templates.
Role-based training with documented competence.
A maintained QMS workspace for daily operation.
Checks, findings and audit-oriented preparation
Fellowship Program
For startups with strong product potential and the discipline to build regulatory structure early — before documentation debt, unclear roles or late audit pressure slow the team down.
Fellowship is not a discount model and not a free QMS. It is a structured IPP investment in selected teams and products — with a defined scope, active Journey work required and clear expectations on both sides.
A serious MedTech direction with a plausible route toward market and a clear product claim.
A team willing to work with roles, evidence and review logic from the start.
No competing product in the active IPP portfolio. Existing customer consent required where relevant.
A scope where guided structure helps the product move forward without overbuilding.
Claim Check (1.920 €), advisory, Expert Reviews, NB support, on-site audits and Easy Expert Custom setup are always billed separately at standard rates. Virtual budget covers Journey stage fees and QMSaaS within the defined scope only. Unused stage budget transfers to the next stage when IPP sign-off is reached ahead of the maximum stage duration.
Case study, logo use and testimonial for IPP communication as agreed.
Structured feedback on new modules and beta participation where relevant.
IPP retains an option on future collaboration or participation. Scope defined at Fellowship start.
Events, community participation and public mentions as agreed.
The startup contributes to IPP's market development in a relevant MedTech segment.
Start smart. Choose how you want to begin.
For startups, we offer a simple entry into professional compliance and quality management.
Build the right foundation and get rewarded.
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