Who owns the file once it's delivered?

You do. We hand over editable source files so your team can maintain and revise the file as the product evolves.

Can you update an existing technical file instead of starting from scratch?

Yes — that's often faster and cheaper. We audit what you have, fill the gaps, and re-structure where needed.

Documentation & Compliance Consulting

Technical Documentation

Complete technical files ready for EU market entry and authority inspection.

Overview

What this service is

Every product placed on the EU market must have a technical file behind it — and that file has to be ready to hand to a market surveillance authority on short notice. We compile that file for you, in English, structured according to the annexes of the directives that apply to your product.

Our files are written to be read. Authorities don't want a dump of every email and CAD revision; they want a clear narrative that shows the product is safe, the right standards were applied, and the evidence exists. That is what we deliver.

Scope

What's included

Product description, intended use, and risk assessment summary
List of applied directives, regulations, and harmonised standards (with editions)
Design and manufacturing drawings, where applicable
Test reports and certificates organised by directive
Draft Declaration of Conformity referenced into the file
Indexed, archive-ready PDF and editable source files

Deliverables

What you receive

Compiled technical file (PDF + editable Word/Markdown sources)

Document index and revision register

Hand-off guide for your internal QA team

Why it matters

The cost of skipping it

Market surveillance authorities can request your technical file at any time. Incomplete or disorganised files trigger product recalls, fines, and forced market withdrawal — even when the product itself is safe.

Who it's for

Typical clients

Manufacturers and authorised representatives who need a defensible technical file before first shipment, before an audit, or before signing a distributor contract that requires one.

Process

How we work

01
Intake
Brief call to scope the product, the market, and the documentation that already exists.
02
Analysis
Gap assessment against the applicable EU directives and harmonised standards.
03
Delivery
Finished file, report, or test results — with a walkthrough call for your team.
04
Follow-up
Corrections and support during external audits or market surveillance.

FAQ

Common questions

Not sure where to start?

Book a 15-minute intro call to discuss your compliance needs.

Book Intro Call