Your QMS. Compliant by Default.
Easy13485 is instantly ready, scalable, and aligned with ISO 13485 & MDR — so you can implement a working QMS in one day, not one year.
Ready-to-use processes
Audit-ready documentation
Training & records included
QMS Feature
Highlights
Built for teams that need results, not paperwork.
EASY13485 combines pre-configured processes, clear ownership, and built-in training into a QMS that actually works in startup reality.
Fully Pre- Configured
No blank templates. All processes aligned with ISO 13485, MDR, ISO 14971, IEC 62304 and more. Define your scope and go live.
1-Day Implementation
Forget multi-month rollouts. With EASY13485, you import, assign roles, and launch your QMS in 24 hours.
Role-Based System
Built around predefined roles and responsibilities. Works with small or cross-functional startup teams.
Living System
Modular process building blocks your team actually uses – not just static PDFs or templates.
Academy - Integrated
Directly linked to learning paths. Each process has built-in training assignments to keep your team qualified and audit-ready.
What Easy13485 actually covers
EASY13485+ is not a bundle of templates. It is a structured compliance system — covering technical documentation, regulatory requirements, and execution-ready processes in one place.
PLC Process
Product Lifecycle & Technical Documentation
End-to-end coverage of design, development, verification, validation, and change control — fully aligned with MDR and FDA expectations.
Fully covered & audit-ready80+ Templates
Pre-filled, structured, regulator-aligned
SOPs, records, plans, and logs that are already mapped to standards — no blank documents, no guessing what auditors expect.
Ready to use from day one300+ Processes
Fully described & interconnected
Every process is explained, linked to roles, inputs, outputs, and evidence — creating real traceability instead of isolated documents.
MDR 2017/745
EU medical device regulation, integrated into the QMS — not handled as a parallel documentation effort.
FDA 21 CFR 820
US Quality System Regulation mapped into processes, records, and design controls.
MDSAP Core
Common audit requirements reused across multiple markets, reducing duplication and audit friction.
ISO 13485
ISO 14971
IEC 62304
ISO 27001
ISO 42001
ISO 14155
All tiles are part of one connected system — executed inside the Makerspace,
not maintained as isolated compliance artifacts.
Not Sexy
But Safe
Our QMS isn’t flashy – and that’s the point. It’s built to pass audits, not beauty contests. 100% structured, tested, and actually usable. Still better than drowning in spreadsheets.
The EASY13485 QMS-Service gives you a fully structured, startup-optimized quality management system that’s pre-configured, pre-filled and audit-ready – with no extra burden on your team.
You don’t need to customize endless templates or “translate” standards into your workflow. With EASY13485, you’re up and running in a day – not in 12 months.
Mapped standards inside
easy13485+
easy 13485 is built as a layered compliance system. Each layer unlocks speed now -- and flexibility later
1
QMS Core
Certification-ready foundation
⌄
QMS Core
Certification-ready foundation
The core of EASY13485+ is a fully mapped ISO 13485 system, extended for EU and US regulatory expectations.
ISO 13485 · full
MDR 2017/745 · full
FDA 21 CFR 820 · full
This means: your QMS is audit-ready, traceable, and credible for investors from day one.
2
Global Market Access
Expand without rebuilding
⌄
Global Market Access
Expand without rebuilding
EASY13485+ already maps the core requirements used by multiple international regulators.
MDSAP Core · full
Health Canada · full
TGA / ANVISA / PMDA · full
This means: entering new markets doesn’t require reworking your entire quality system.
3
Security & AI Governance
Future-proof compliance
⌄
Security & AI Governance
Future-proof compliance
Beyond classic QMS, EASY13485+ integrates governance standards that are becoming mandatory for enterprise customers and AI-based products.
ISO 27001 · full
ISO 42001 · full
This means: fewer blockers in security reviews, AI assessments, and enterprise procurement.
In the Makerspace, these layers are translated into
weekly execution and real audit evidence.
Discover
The Makerspace
⚙️
QMS-Service
Easy13485 combines the speed of an out-of-the-box solution with the flexibility to reflect each team’s specific setup.
🎓 Academy
🎓
Academy
Designed to develop high potentials—like top consulting firms—the Academy turns training into a strategic growth tool.
📄
Tech-Doc.
Consultants are used strategically, not permanently.
💻 Certificator.AI
Answers in seconds, so teams stay in flow and budgets stay lean.
🧾 Audit Support
Confidence on audit day—fewer findings, fewer costly loops.
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OR
First Contact -
Your Choice
First Contact -
Your Choice
Start smart. Choose how you want to begin.
For startups, we offer a simple entry into professional compliance and quality management:
E-Learning & free Consulting call
Build the right foundation and get rewarded.
- “16 Obligations of a Manufacturer” course
- Certificate after completion
- First consulting call included – free
Direct Consulting
Start immediately with tailored expert support.
- First consulting hour: €162
- No prerequisites
- Startup-focused, practical guidance