IPP · Easy13485 Makerspace
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.
The Easy13485 Journey
Most MedTech startups don't fail because of missing templates. They struggle because product development, documentation, quality management and regulatory requirements evolve separately. Easy13485 brings them together — from claim clarity to planning, evidence, automation and operated QMS practice.
The five capabilities
Each capability of the Easy13485 Makerspace gives MedTech founders the structure and acceleration they need — the Journey sells the path, the capabilities prove it.
Technical documentation grows with your development — from clinical data and design input to verification and validation. Evidence stays connected to your QMS from the start.
Easy ExpertAI-guided access to the Easy13485 structure: processes, roles, tasks, templates and evidence logic. Answers are model-based, source-bound and connected to how Easy13485 works.
Academy & Role TrainingRole-based training helps each team member understand their responsibilities, processes and required evidence. Training becomes part of the Journey — not a separate learning project.
QMSaaSA maintained Easy13485 workspace with roles, processes, documents, training and evidence structure. Your QMS becomes a working environment, not just a folder system.
Readiness Audit & Audit SupportReadiness 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.
Not a consulting program
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. If you want to build your quality management system independently, correctly and without detours, the Makerspace is your starting point.
What our customers say
From SaMD and diagnostics to device teams — startups use the Easy13485 Makerspace to move faster, reduce cost 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 — the quickest, safest way to start generating revenue."
"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 certification timeline."
"For a Class IIa startup, the speed mattered: we reached ISO 13485 certification in about five months. What stood out was the structure and the full cost transparency — no surprises along the certification timeline."
Start here
Two ways in — explore the structured path yourself, or talk it through with an expert first.
See the stages from Claim Check to operated QMS, and find where your product fits.
Start with a first consulting call, 120 € (45 min), startup-focused and practical.
What our customers say
From SaMD and diagnostics to device teams — startups use the Easy13485 Makerspace to move faster, reduce cost 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 — the quickest, safest way to start generating revenue."
"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 certification timeline."
"For a Class IIa startup, the speed mattered: we reached ISO 13485 certification in about five months. What stood out was the structure and the full cost transparency — no surprises along the certification timeline."
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.
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
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.
