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.
Each pillar of the Easy13485 Makerspace is designed to give MedTech founders
the structure and acceleration they need — from the first idea to CE certification.
Together they form a lean regulatory framework that transforms compliance
into a driver of innovation, trust, and growth.
A pre-configured ISO 13485 system, individually tailored to each startup. Roles, SOPs, and approvals are in place immediately — startups are audit-ready from day one.
Easy13485 combines the speed of an out-of-the-box solution with the flexibility to reflect each team’s specific setup.
Technical documentation is embedded in the QMS, supported by structured MDR/ISO templates. Startups stay in the driver’s seat, while regulatory guidance is provided only when needed.
Consultants are used strategically, not permanently.
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
Easy13485 combines the speed of an out-of-the-box solution with the flexibility to reflect each team’s specific setup.
Designed to develop high potentials—like top consulting firms—the Academy turns training into a strategic growth tool.
Consultants are used strategically, not permanently.
Answers in seconds, so teams stay in flow and budgets stay lean.
Confidence on audit day—fewer findings, fewer costly loops.
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.
Start immediately with tailored expert support.
Ein frühzeitig aufgebautes QMS ist für MedTech-Startups der Schlüssel zum Marktzugang. Das Praxisbeispiel von tendexx zeigt, wie ein schlankes Qualitätsmanagement mit Easy13485 Zeit spart, Kosten senkt und regulatorische Hürden reduziert.
Mit dem Easy13485 Release 4.5.0 wurden zentrale Verbesserungen aus Audits und Praxis umgesetzt. Neue Templates, erweiterte CAPA-Prozesse und SaMD-Ergänzungen sorgen für mehr Klarheit und Sicherheit bei der MDR-Umsetzung.
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.
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.
Vom Patienten zum Unternehmer: Diese MedTech-Gründerstory zeigt, wie persönliche Erfahrung zur treibenden Kraft für Innovation wird. Mit Struktur, Easy13485 und Unternehmergeist entsteht aus einer Idee ein Projekt mit nachhaltigem Nutzen.
