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
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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.