Technical Documentation — Done Right, First Time

Ship documentation with confidence. Use guided, MDR/ISO-aligned templates and in-context help to build a clean, auditable file without the guesswork.

Technical Documentation Module

What’s included

  • MDR/ISO-aligned template library (design, risk, usability, software, validation, IFU)
  • In-context guidance connected to roles and EASY13485 processes
  • Approval workflows with history, comments, and sign-offs
  • Traceability across inputs, decisions, and outputs
  • Export clean, audit-ready documentation sets
Start Your Documentation
MDR/ISO alignment

Built around MDR, ISO 13485, ISO 14971, IEC 62304, IEC 62366, IEC 82304-1.

Role-aware

Responsibilities and approvals mapped to your team’s roles.

Fewer errors

Guided inputs reduce omissions, inconsistencies, and rework.

Audit-ready

Clean exports and traceability that stand up to scrutiny.

How it works

1) Pick the right template

Design file, risk file, IFU, validation plan—mapped to MDR/ISO requirements.

2) Fill with guidance

Inline hints, examples, and references—reduce back-and-forth and rework.

3) Review & export

Approvals and traceability built-in. Export audit-ready packages in one click.

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

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.

OR

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
Contact
Office hours
Monday to Friday
8:00 am - 2:00 pm