Send us your existing technical documentation and we will show you, document by document, how it maps to a structured MDR technical file in Obodux: what is already covered, what we can consolidate for you, and where your files hold detail or gaps worth discussing. The analysis is free and there is no obligation.

It is the quickest way to see what moving your technical file into Obodux would involve, before you commit any time to a trial.

What the gap analysis covers

We compare your documents field by field against the twelve structured sections Obodux uses for a technical file, aligned to MDR Annex II and Annex III.

Every observation carries an MDR context label (directly addresses MDR, supports MDR documentation, or additional depth). Observations are discussion points, not a compliance assessment or severity rating.

What a real report looks like

From an anonymised analysis of a Class IIa device moving from an MDD certificate towards an MDR submission:

The 13-page report includes an executive summary, methodology, the three parts above, summary statistics and a document-to-section mapping. Email us for the anonymised sample.

How it works

1. Send your documents

   Share your technical file, or the sections you want reviewed. Redacted documents are fine.

2. We map them

   Obodux ingests the documents and compares them field by field against its MDR-aligned structure.

3. You get a written report

   A clear report of what is covered, what would be consolidated and what is worth discussing.

4. Talk it through

   We walk your team through the findings and what onboarding to Obodux would look like.

Who it is for

• Manufacturers moving a legacy MDD technical file to EU MDR (see MDD to MDR migration)
• Teams with an EU MDR technical file spread across Word, Excel and SharePoint
• Manufacturers preparing a UKCA technical file for Great Britain
• RA/QA leads who want an objective view of their documentation before a notified body review

Common questions