Your QMS. Compliant by Default.
Instantly ready, scalable, and fully aligned with ISO 13485 & MDR — get your quality management system implemented in one day, not one year.
Why Article 10 MDR matters
You’re building a product that changes lives — not a binder for an auditor’s shelf. That’s why EASY13485 gives you a ready-to-use, compliant QMS with role-tested templates and all relevant processes described and continuously kept up to date.
Under Article 10 of the MDR, manufacturers must operate a fully documented and maintained quality management system covering design, risk, clinical evaluation, vigilance, and post-market surveillance — without gaps. Missing or incomplete processes can block your CE mark and delay market access.
Skip months of setup and get audit-ready in one day — so you can focus on what really matters: shipping, scaling, and winning your market.
QMS Feature Highlights
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.
Not sexy.
Just safe.
Just 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.
What’s Included
Everything your MedTech startup needs to comply with ISO 13485 and MDR — no guesswork, no bloat. A ready-to-use, compliant QMS with role-tested templates and clearly described, continuously maintained processes from day one.
Quality Manual
Structured and aligned with ISO 13485 and MDR — clear scope, interfaces, and ownership.
Core Processes
Design & development, risk, vigilance, validation — described, aligned, and kept up to date.
Ready-to-Use Templates
Risk matrices, change control, traceability tables — implementation-ready and review-friendly.
Academy Link-Up
Each process connects to its matching learning path — auto-assigned by role with audit-grade tracking.
Role Matrix
Responsibility, authority, and ownership clearly assigned for every function — audit-ready clarity.
Scope & Exclusions
Documented applicability and justified exclusions for MDR, ISO 13485, IEC 62304, ISO 14971, and more.
Frequently Asked Questions
How fast can we go live with the QMS?
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Can I only use selected modules or do I need the full Makerspace?
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Is the system valid for MDR and ISO 13485 certification?
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How does the Certificator.AI chatbot work?
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