Regulatory & Clinical Evidence (Neuro/SaMD)
Evidence meant to stand up.
Use this for
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You’re shaping performance claims and need the evidence to back them.
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Reviewers will ask “why this measure, in this population, at this time?”
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You’ve got lab/field results that must become a clinical evaluation narrative.
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PMCF/PMS can’t be a checkbox—you need signals you can act on.
What you walk away with
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Claims & evidence map — what you can say now vs. later, and why.
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Clinical evaluation core — appraisal tables, synthesis, bias notes (PRISMA-aligned methods).
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Study scaffolding — protocol synopses, endpoint tables, SAP shells tied to claims.
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Risk–evidence linkage — traceability across claims, IFU, usability, and residual risk.
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Post-market plan — PMCF/PMS signals, thresholds, owners, and timelines.
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Submission-ready text blocks — methods/results/limitations written like a reviewer would.
Patterns we reach for
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Annex XIV logic front-to-back (EU MDR): state claims → appraise → synthesize → conclude.
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PRISMA protocol: searches, screening logs, reproducible flow.
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Fit-for-purpose endpoints: measure choice justified; context of use explicit.
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Stackable evidence: lab → field → trial glide path, documented limits.
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Risk first: claims tied to hazards, IFU, and human-factors outcomes.
Quality gates
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Every claim ↔ specific evidence (strength, limits, population).
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Transparent appraisal (inclusion/exclusion, bias, certainty of evidence).
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Traceability table (risk ↔ claims ↔ IFU ↔ usability) in one place.
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PMCF/PMS with real triggers (drift/harm thresholds, who watches what, when).
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Re-use ready: figures/tables portable to submissions, boards, and manuscripts.
Rapid · 2–3 weeks
Claims & clinical evaluation core
- Claims→evidence map, appraisal tables, PRISMA framework, reviewer-grade summary.
- Gap list + fastest path to reliable claims.
Build · 6–10 weeks
Complete clinical evaluation
- Full synthesis, figures/tables, endpoint & schedule tables, SAP snippets.
- PMCF/PMS plan with signals & governance, risk–evidence linkage.
Oversight (Quarterly/Monthly)
Post-market evidence loop
- Literature sweep, signals dashboard, drift/harm gates, change-control notes.
Example runs
EU MDR CER (neuro focus) with CEP, appraisal, PMCF scaffolding.
SaMD clinical evaluation: analytical → clinical performance → usability linkage.
Systematic review for a cognitive endpoint with bias appraisal & metaanalysis.
Risk–evidence linkage tying claims to IFU and human-factors residual risk.
Boundaries
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We only prepare evidence you can defend.
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If a claim isn’t supportable, we’ll be sincere about it—and show the shortest path to make it real.
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“Real-world evidence” needs design, QC, and limits; we document all three.
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Ship claims you can stand behind.
Turn ideas into results that travel.
Book a 15-minute consultation or request the clinical-evaluation sample pack.
FAQ
Will you write the full CER/CEP?
Yes—by arrangement. We can also deliver the clinical evaluation core if you author internally.
Do you support FDA expectations?
We align evidence and claims with FDA guidance and your regulatory counsel’s strategy.
Can this connect to our trials or SaMD features?
Yes—endpoints, usability, and AI components connect via the risk–evidence table and monitoring plan.
Who runs PMCF/PMS studies?
We design protocols/tools/dashboards; you or your CRO/site must collect data.
How do you handle updates and model changes?
We define evidence triggers and document impacts on claims, risk, and labeling.
Need Some Help?
Feel free to contact us for any inquiry or book a free consultation.
