Easy13485 gives MedTech startups a ready-to-use ISO 13485 QMS — templates, training, and expert guidance included. Get audit-ready while staying focused on building your product.
The Easy13485 Makerspace is where
innovation meets compliance.
Built around our Easy13485 system, it gives MedTech startups
everything they need to turn prototypes into certified products –
faster, leaner, and audit-ready from day one.
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.
Scan the steps, open what you need, and see exactly what you get inside the Makerspace — and what outcome it creates.
Scope & Gap Analysis (done with you, not to you)
Align scope, owners, and the audit pathway in one session.
We define your MDR/ISO scope, assign owners, and lock the audit pathway. You leave the first session with a plan your team can execute immediately.
EASY13485 does the heavy lifting
Templates → tailored docs, fast approvals.
We plug in a ready-to-use ISO 13485 QMS (SOPs, matrices, records) and tailor only what’s specific to your product. Fast alignment, fast approvals.
Coaching rhythm + evidence every week
Coaching + continuous evidence creation.
We run a lightweight cadence: design decisions, supplier work, risks, training — all captured as audit-ready evidence as you build.
Mock audit → CAPA closure (~2 weeks)
Find gaps early, close CAPAs before NB.
We run a realistic internal audit, package your audit evidence, and close CAPAs before a Notified Body ever sees them.
Stage 1 & 2 → certificate
Stage 1 + 2 with coached findings closure.
We support you through Stage 1 and Stage 2, coach responses, and drive findings to closure so you reach certification fast and credibly.
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
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.
Caire wurde mit dem Easy13485 ConnectAward 2025 ausgezeichnet. Als erstes vollständig zertifiziertes Unternehmen steht Caire für pragmatische Umsetzung, aktives Community-Feedback und Regulatory Excellence im MedTech-Umfeld.
Ein Praxiswochenende in Erlangen zeigt, wie Easy13485 QM Service MedTech-Startups konkret unterstützt. Der Austausch zu MDR und ISO 62304 macht deutlich, warum pragmatische Prozesse Zeit sparen und regulatorische Hürden frühzeitig entschärfen.
Der Smart Health Investor Circle zeigt die Stärke des Quhr Ökosystems. Hochwertiger Austausch mit Investoren, spannende Startup-Pitches bei WERK-X und ein starkes Innovationsumfeld machen deutlich, wie lebendig das Gesundheits-Startup-Netzwerk in NRW ist.
