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Checklists & templates

Working documents, not gated PDFs.

Short, practical checklists our own teams use. Ask for one and a person sends it, with no drip campaign attached.

Available on request

What we will send you.

Each one is a working document rather than a marketing asset. If it does not help, tell us and we will improve it.

01

EU MDR technical file checklist

What a notified body will look for, annex by annex, with the items most commonly found thin.

02

IVDR readiness checklist

For manufacturers whose products moved out of self-certification and into a higher risk class.

03

CSV traceability matrix template

Requirement through risk assessment to test evidence, in the structure an inspector can follow.

04

Inspection readiness checklist

What to have ready, who should be briefed, and the questions that get asked first.

05

CAPA effectiveness check guide

How to close a CAPA to demonstrated effectiveness rather than to a date.

06

Contractor onboarding checklist

I-9 and E-Verify, background screening and GxP-aligned checks, in the order that avoids delaying a start date.

Ask for one

Tell us which and we will email it. No account, no sequence.

Talk to someone who has done this.

Hiring for it, or looking for the work. Either conversation is welcome.

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