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Product scope & device types
Non-active medical devices, Software as a Medical Device (SaMD), medical electrical systems, and custom-made products.
Technical Documentation
built along your Product Life Cycle.
Technical documentation isn’t created at the end.
With EASY13485, it is built step by step along your Product Life Cycle — fully aligned with ISO 13485 and MDR from day one.
From Product Idea to Declaration of Conformity
The Product Life Cycle as the backbone of your Technical Documentation
EASY13485 guides you through every phase of product development — from defining the intended use to signing the Declaration of Conformity. Technical documentation is created as a natural outcome of development work, not as a separate task at the end.
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PLC-aligned templates
50+ ready-to-use documents
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Product-specific
individualized to your device
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Startup-friendly
QMS-connected, dev-ready
What is covered along the PLC
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Phase-by-phase guidance
Clear activities and defined outputs for each PLC phase — no guessing what comes next, no missing steps.
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Templates mapped to the PLC
50+ audit-tested templates aligned with MDR Annex II & III and ISO 13485 development logic.
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QMS-connected evidence
Records, approvals, and traceability remain consistent across QMS processes and development activities.
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Modules when needed
Software, electronics, mechanics, usability, clinical evaluation, and risk management — seamlessly integrated.
Complete
All required development steps and documentation outputs are covered across the full life cycle.
Consistent
One connected system — aligned terminology, logic, and traceability across all documents.
Audit-ready
Evidence exists continuously and can be reviewed at any point — not just before certification.
Regulatory frameworks covered
EASY13485 structures your technical documentation around the standards and MDR requirements that auditors and notified bodies actually assess — aligned to the PLC and connected to your QMS.
Quality & Risk
- DIN EN ISO 13485:2021 — Medical devices QMS
- EN ISO 14971:2019 + A11:2021 — Risk management
Technical Documentation
- MDR Annex II & III — Technical documentation structure
- MDR Chapter II (Article 10) — Manufacturer obligations
Usability & Clinical
- IEC 62366-1:2015 + A1:2020 — Usability engineering
- Clinical evaluation — evidence and documentation logic (module)
Software (where applicable)
- IEC 62304:2006 + A1:2015 — Software lifecycle processes
- IEC 82304-1:2017 — Health software
- IEC 81001-5-1:2022 — Health software security
Scope depends on product type and classification (e.g., software, electrical systems, custom-made). The framework helps you apply the right requirements without building everything from scratch.
Ready to build Technical Documentation the “PLC way”?
Stop retrofitting documents. Use a product-life-cycle driven workflow that produces audit-ready evidence continuously — aligned with ISO 13485 and MDR Annex II & III.
Get clarity
Define scope, device type, and the right documentation path.
Get structure
PLC-aligned templates and outputs mapped to real development work.
Get momentum
Startup-friendly execution — with optional expert reviews when needed.
Prefer async? Send your scope and we’ll recommend the right pathway.
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
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Academy
Designed to develop high potentials—like top consulting firms—the Academy turns training into a strategic growth tool.
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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.
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
Office hours
Monday to Friday
8:00 am - 2:00 pm
8:00 am - 2:00 pm