Buy the decision, not the deck.
Every assessment produces the same controlled artefacts: a recorded decision per perimeter, the reasoning behind it, and the evidence index that makes it defensible. Defined scope, a written quote before work begins, and a stated delivery date.
Snapshot Regulatory Impact Assessment
One device, one protocol, assessed against all seven perimeters — with the reasoning recorded, not just the conclusion.
- Snapshot RIA report with a recorded decision per perimeter
- Decision register entry, versioned and prepared for filing to your TMF
- Trigger list: what would change the answer, and when to re-assess
- Evidence index referencing every document relied on
- A 45-minute readout with the specialist who did the work
Full Multi-Perimeter Assessment
Multiple devices or multiple jurisdictions, where the answers differ by market and the interactions matter.
- Full assessment across every device and jurisdiction in scope
- Comparative jurisdiction matrix showing where answers diverge
- Complete decision register with per-device entries
- Consolidated trigger register across the portfolio
- Evidence index and gap list with remediation priorities
Mid-Study Change & Trigger Assessment
A firmware release, OS update, algorithm retrain or supplier change has landed. Documentation only, bridging evidence, or full revalidation?
- Change classification — minor (documentation only), moderate (bridging evidence) or major (full revalidation) — with the rationale
- Impact assessment across affected perimeters
- Required actions with evidence expectations for each
- Updated decision register entry preserving the prior version
- Protocol amendment impact note where relevant
Fit-for-Purpose Validation Package Review
You have a validation package. We tell you whether it would survive contact with an inspector, and what is missing.
- Gap analysis against ISO 14971, IEC 62366-1, the FDA QMSR (21 CFR Part 820), EU MDR Annex I and ICH E6(R3)
- Endpoint-specific fitness opinion: does the evidence support this measurement, for this population, in this setting
- Prioritised remediation list with effort estimates
- Evidence index of what you already hold and where it sits
Inspection Readiness Evidence Pack Review
A mock inspection of your device evidence, before a real one finds the gaps.
- 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
Portfolio Governance — ongoing
A retained arrangement keeping the decision register current across your device estate, with scheduled re-assessment. Automated trigger monitoring is in development; today the watch is run by a named specialist to an agreed cadence.
- Maintained decision register across every device and study
- Scheduled re-assessment, and re-assessment on notified change — run by a specialist
- Quarterly portfolio review and risk report
- Regulatory change watch across your jurisdictions
- Named specialist and an agreed response time
Distributor DHT Readiness Review
The evidence a sponsor's vendor-qualification team asks for — built from the obligations a distributor actually carries, not the sponsor's list.
Manufacturer Sponsor-Pack Audit
The documents a CRO needs on day one, assembled and gap-checked from the sponsor's side of the table — before the vendor audit, not after.
How an assessment runs
Four steps. You will know at every point what we hold, what we need and what happens next.
Tell us about the device and the protocol
A structured intake: the technology, what the protocol asks it to do, which endpoints or safety decisions depend on it, the jurisdictions, and who supplied it. Ten minutes if you have the protocol to hand.
We confirm scope, price and date
You receive a written quote before work begins. You accept it before we schedule the assessment.
We assess every perimeter in scope — all seven for a Snapshot
Each one recorded with its reasoning, not just its conclusion, so the decision survives staff turnover and stands up to challenge.
You receive a controlled package
Report, decision register and evidence index, versioned and downloadable from your dashboard. Every access is logged, and the package is prepared for filing under your own TMF conventions.
Not sure which assessment fits?
Tell us the device and the protocol. In fifteen minutes we will tell you which assessment answers your question, or that you do not need one yet.
Book a 15-minute call