Easy13485 Makerspace is the QMS and Regulatory Operating Model for MedTech startups and SMEs. Follow the Easy13485 Journey from claim clarification and product planning to technical documentation, QMS operation and audit readiness — without building everything from scratch.
Most MedTech startups do not fail because of missing templates.
They struggle because product development, documentation, quality management and regulatory requirements evolve separately.
Easy13485 brings them together.
The Easy13485 Journey guides teams from claim clarification through development, verification and technical documentation to QMS operation and audit readiness — using a structured QMS and Regulatory Operating Model built for MedTech.
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.
Each capabilit of the Easy13485 Makerspace is designed to give MedTech founders
the structure and acceleration they need – from the first idea to CE certification.
Technical documentation grows with your product development – from clincal data and design input to verification, validation.Evidence stays connected to your future QMS right from the start.
Easy Expert gives AI-supported access to the Easy13485 structure: processes, roles, tasks, templates and evidence logic.Answers are model-based, source-bound and connected to the way Easy13485 works.
Role-based training helps each team member understand their responsibilities, processes and required evidence..
Training becomes part of the Journey — not a separate learning project.
QMSaaS provides a maintained Easy13485 workspace with roles, processes, documents, training and evidence structure.
Your QMS becomes a working environment, not just a folder system.
Readiness audits check whether roles, evidence, documents and QMS operation are robust within the agreed scope
Audit readiness is built through daily operation — not last-minute cleanup.
The Easy13485 Makerspace is not a consulting program. It is a structured
system that guides you step by step toward audit readiness – developed
exclusively for Easy13485 customers and deliberately separated from
traditional IPP consulting services. If you want to build your quality
management system independently, correctly, and without detours, the
Makerspace is your starting point.
Real results from SaMD, diagnostics, and device teams using the Easy13485 Makerspace to move faster,
reduce costs, and stay audit-ready.
“We moved from the decision to go with EASY13485 to CE mark in less than 5 months.
For our Class I product, the Makerspace provided exactly the structure and guidance we needed.
It wasn’t just fast — it was the quickest, safest way to start generating revenue.”
Philipp Emonds
Coreway, Class I
“With IPP’s support we achieved ISO 13485 certification in just 5 months.
The process was fast, structured, and completely transparent on costs.
For a Class IIa startup like ours, that speed is crucial for our medical device certification timeline.”
Baturay Yalvaç
· Breathment, Class I
“With IPP’s support we achieved ISO 13485 certification in just 5 months.
The process was fast, structured, and completely transparent on costs.
For a Class IIa startup like ours, that speed is crucial for our medical device certification timeline.”
Mohtadi Ben Fraj
· caire.ai, Class IIa start-up
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
Easy13485+ is an integrated QMS/ISMS for MedTech SMEs. It moves standards traceability from the manual level to the process level, with 619 auditable norm mappings and transparent verification results: 0 Major, 2 Minor and 3 Observation.
Auf dem Swiss MedTech Day 2026 treffen sich healthcare projects consulting & management (Frank Stein) und ipp: professionelles MedTech-Projektmanagement und regulatorische Erfahrung verbinden sich mit der startup-tauglichen QMS-Struktur von Easy13485. Ein geführter Einstieg in Regulatory Affairs, ISO 13485, MDR und Marktzugang – ohne dass Startups dafür sofort eine eigene Abteilung aufbauen müssen.
2LIP is moving from research toward a real medical device product. With Easy13485 Makerspace, the team can build QMS, technical documentation and audit-ready evidence step by step along the product life cycle.
CAIRE Health AI GmbH has successfully completed the ISO 13485 surveillance audit by the Notified Body — with no major findings and no minor findings. The result shows that the QMS has not only been implemented, but is being used in daily operations.
Easy13485 4.7.0 adds ISMS-related improvements for MedTech startups building SaMD, connected devices or hospital-facing systems. ISO 13485 remains the regulatory backbone, while ISO/IEC 27001 maturity can be added when product, customer or partner requirements make it relevant.
If you’re building SaMD, you can’t treat ISO 13485 (MDR) and ISO/IEC 27001 (ISMS) as separate projects anymore.
Release 4.6.0 integrates both into one lean, startup-operable QMS—without creating a second process landscape.
