Easy13485 is instantly ready, scalable, and aligned with ISO 13485 & MDR — so you can implement a working QMS in one day, not one year.
EASY13485 combines pre-configured processes, clear ownership, and built-in training into a QMS that actually works in startup reality.
No blank templates. All processes aligned with ISO 13485, MDR, ISO 14971, IEC 62304 and more. Define your scope and go live.
Forget multi-month rollouts. With EASY13485, you import, assign roles, and launch your QMS in 24 hours.
Built around predefined roles and responsibilities. Works with small or cross-functional startup teams.
Modular process building blocks your team actually uses – not just static PDFs or templates.
Directly linked to learning paths. Each process has built-in training assignments to keep your team qualified and audit-ready.
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.
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-readyPre-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 oneFully described & interconnected
Every process is explained, linked to roles, inputs, outputs, and evidence — creating real traceability instead of isolated documents.
EU medical device regulation, integrated into the QMS — not handled as a parallel documentation effort.
US Quality System Regulation mapped into processes, records, and design controls.
Common audit requirements reused across multiple markets, reducing duplication and audit friction.
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.
The core of EASY13485+ is a fully mapped ISO 13485 system, extended for EU and US regulatory expectations.
This means: your QMS is audit-ready, traceable, and credible for investors from day one.
EASY13485+ already maps the core requirements used by multiple international regulators.
This means: entering new markets doesn’t require reworking your entire quality system.
Beyond classic QMS, EASY13485+ integrates governance standards that are becoming mandatory for enterprise customers and AI-based products.
This means: fewer blockers in security reviews, AI assessments, and enterprise procurement.
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.