Technical Documentation — Technical Files, DHF & CER
Technical files rarely fail because the product is bad. They fail because the documentation cannot prove what the product does — a GSPR checklist that does not trace to evidence, a clinical evaluation that leans on outdated data, a design history file with gaps a reviewer can drive through.
Confiquora builds and remediates technical documentation that withstands notified body scrutiny: structured to EU MDR Annex II/III, traceable from requirement to evidence, and maintained as a living system rather than a one-time deliverable.
What you get
- Notified-body-ready technical files
- Traceable design history files
- Defensible clinical evaluations
- GSPR alignment throughout
Standards & frameworks we work in
How an engagement runs
Discovery → Gap Assessment → Strategy → Implementation → Certification → Ongoing Support. Every engagement follows the same spine — scoped in the first call, priced before we start, and handed over with your team trained to run what we build.
Frequently asked questions
What does a technical file gap assessment involve?
We audit your existing file against EU MDR Annex II/III and current notified body expectations, then deliver a prioritized remediation plan — what fails, why it fails, and the order to fix it in.
Do you write clinical evaluation reports?
Yes — CERs per MEDDEV 2.7/1 rev4 and MDR Article 61, including literature search protocols, equivalence justification, and post-market clinical follow-up planning.
Can our team maintain the file after you build it?
That is the goal. We hand over templates, traceability structure, and training so document control stays in-house.
Talk it through with us
Free 30-minute consultation. No obligation — just a clear read on where you stand and what it takes.
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