In our Easy13485 Makerspace story today, we introduce the team behind 2LIP — a MedTech startup moving from research toward a real medical device product.
2LIP is a team of four enthusiastic researchers and part-time founders taking responsibility for the safety and effectiveness of their medical device product.
This is exactly why we built the Easy13485 Makerspace.
Too many MedTech teams lose momentum because they believe they first need to fully understand every regulatory detail before they can start building.
Our view is different:
You should be able to start early, develop step by step and build your regulatory structure alongside the product life cycle — not months later.
The point of the Easy13485 Makerspace is simple:
You should not have to get lost in regulations before you can start building.
With Easy13485 Makerspace, teams can start right away, work along the product life cycle and build their QMS, technical documentation and audit-ready evidence step by step.
With the Easy13485 Journey, 2LIP can grow from early claim and development planning to structured technical documentation, QMS operation and audit-ready evidence – without having a full-time QA/RA in place from day one.
Structured for compliance from day one, so MedTech teams can keep building while becoming audit-ready.
That is exactly the Easy13485 Makerspace idea:
Regulatory work is not outsourced blindly and not left to the founders alone.
The Easy13485 structure enables the team to share the regulatory load, keep building and become more structured, more traceable and better prepared for audits step by step.
Audit readiness is built along the way and not added at the end.
Great progress so far, Carolin Schulz and Team. We are looking forward to the next steps of 2LIP.
Auditfestes ISO-13485-System – mit klaren Befunden und wirksamen CAPAs.
Komplexe Projekte stabil führen – bis Meilensteine wirklich erreicht sind.
Klinische Evidenz ordentlich aufbauen – passend zu GSPR und PMCF-Erwartung.
DHF/TF strukturiert aufsetzen – Lücken schließen, Nachweise finden. Prüffähige Struktur nach Anhang II.
Regulatory aus einer Hand – von Submission bis Change Control. Pragmatisch, fristgerecht und dokumentiert.
Schlanke Prozesse, die im Audit funktionieren – und im Alltag laufen.