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Inspection Readiness Evidence Pack Review

A mock inspection of your device evidence, before a real one finds the gaps.

Request this assessment See the method
Fee quoted on scope
scoped per engagement
2–4 weeks
typical turnaround
7
perimeters assessed

Inspection readiness is a state, not an event

A gap found in the weeks before an inspection is the most expensive kind to find: the cost of fixing it is highest and the options are fewest.

We run the inspection first — against the expectations an inspector brings to your role — and hand you the findings while they are still cheap to close. For sponsors and CROs that means ICH E6(R3) Good Clinical Practice and, in the US, FDA bioresearch monitoring (BIMO) of the obligations in 21 CFR 312 and 812. For manufacturers it means the FDA QMSR (21 CFR Part 820), ISO 13485:2016 and notified-body expectations.

✓Decision BasisEvidenceWho signedno attributable signaturefinding written the way an inspector writes it — before an inspector does

Who this is for

Sponsors and CROs with an inspection scheduled, an inspection expected, or a submission where device evidence will be examined. It also suits organisations with no inspection in sight who have simply never tested whether the device file would hold — which is the cheapest moment to find out. It suits you if your device decisions are defensible in the heads of the people who made them and not yet on paper.

What you receive

  • Evidence index across every device in the study
  • Mock inspection findings, written the way an inspector would write them
  • Traceability check: decision → basis → evidence → who signed
  • Prioritised remediation plan with owners and dates
  • Evidence bundle assembled and indexed, prepared for inspection

What you provide

  • Device inventory and current documentation
  • The TMF structure you use
  • Prior audit or inspection findings
  • Training records and change history

More details

What you provide
The device inventory and the documentation currently held for each item. The TMF structure you use, because findings are only useful if they point at the folder the inspector will open. Prior audit or inspection findings, including anything closed — repeat findings are graded harder than first findings. Training records and the change history for each device. Send what exists; the absence of a document is itself a finding, and we would rather record it than have you assemble a package for us.
What is excluded
This is a review of device evidence for one study or one defined estate. It does not include: closing the findings it raises; a certification audit against ISO 13485 or any other standard — we are not a certification body and this review confers no certificate; review of the wider quality management system beyond the device evidence in scope; representation of your organisation to an inspector or notified body; and it is not legal advice. Findings are written the way an inspector would write them, but a real inspector is not bound to reach the same conclusions — or to stop where we stopped.
What happens next
Findings are graded and ordered by what they would cost you in a live inspection, not by how easy they are to fix. Each one carries an owner and a date, so the remediation plan is a plan rather than a list. Where the gaps are documentary, closing them is a matter of writing and approval rather than new evidence. Where they are evidentiary, you have the lead time you would not have had in the fortnight before an inspection. A re-check against the closed findings can be scheduled by agreement, and estates of any size normally move into scheduled governance afterwards, because readiness decays.
What the output looks like

You receive a single controlled package:

1. Evidence index: every device in the study, every document held for it, indexed and located, so the pack can be produced on request rather than reconstructed.

2. Mock inspection findings: graded and written in inspection language, each one referencing the requirement it fails and the evidence that would have satisfied it.

3. Traceability check: decision → basis → evidence → who signed, tested end to end, with every break in the chain recorded.

4. Prioritised remediation plan: findings ordered by exposure, each with an owner, a date and a definition of closed.

5. Assembled evidence bundle: the pack itself, indexed and prepared for inspection under your own TMF conventions.

Where this sits among the eight

Every assessment leaves the same controlled artefacts — a recorded decision, the reasoning behind it, and the evidence index that makes it defensible. They differ in scope. This one is the evidence, read the way an inspector reads it.

This review deliberately stops at the findings. Closing them is the Regulatory & Audit Readiness Fast-Track.

See all eight side by side →

Request this assessment

Tell us about the device and the protocol. We come back with a written scope, price and date — no obligation.

Name, manufacturer and model if you have it. List every item if there is more than one.
The single most important field. Screening, primary endpoint, secondary endpoint, safety monitoring, engagement only?
Which specific endpoints, and whether any safety decision is informed by its output.
e.g. EU, US, UK, Japan, Canada, China.
Who supplies it, whether you relabel, reconfigure or assemble kits, and whether you import into the EU.
Firmware or app updates expected, protocol amendments planned, algorithm retraining, supplier changes.
Vendor declarations, CE certificates, validation reports, prior assessments, DPIAs.
A date or a milestone.

We treat everything you send as confidential and handle it in line with our Privacy Policy. Do not include patient-identifiable data — we never need it.

Before you buy: the service overview

Free, no account needed. Every service line and the framework each is written against.

Brochure

qointa service overview

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Two papers behind this assessment

Free to read with a qointa account. No sales call attached.

You Can Delegate the Work, Not the Accountability: Vendor Qualification and Oversight under ICH E6(R3) Position papers

You Can Delegate the Work, Not the Accountability: Vendor Qualification and Oversight under ICH E6(R3)

The sponsor’s duty to qualify and oversee its DHT vendors — distinct from who holds the economic-operator role.

Read the summary →
The End of the Device: Decommissioning, Retention and Disposal in Digital Trials Position papers

The End of the Device: Decommissioning, Retention and Disposal in Digital Trials

Recovering, wiping, retaining and disposing of trial devices and the data they hold — the lifecycle stage the assessment forgets.

Read the summary →

All papers in the library →