Trusted by CRAs, investigators & sponsors across the EU

Regulatory compliance that catches gaps before they become backlog

Expert regulatory strategy, clinical evaluation and quality compliance for medical device manufacturers — paired with GCP Comply, the platform that keeps every study audit-ready, every day.

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Our platform

Compliance that works as hard as your CRAs do

Built with CRAs and investigators, not just for them. GCP Comply checks every study against ICH E6, ISO 14155:2026, EU MDR/PMCF, ISO 13485 and FDA BIMO — and shows exactly where the gaps are before a monitor ever has to ask.

app.setumed.eu — Sponsor checklist

Study SM-2026-014 · Sponsor role

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Risk management plan (ISO 14971)

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CEC/DMC governance — ISO 14155:2026

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PMCF report — due in 12 days

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Essential documents (Annex II/III)

Live preview — gaps and due dates update automatically as your team works

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39 checklist items mapped to CRA, Site/PI, Sponsor & QA roles

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ISO 14155:2026 built in — CEC/DMC governance, decentralised trials

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AI-drafted clinical synopsis in minutes, not weeks

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Deviation log, document store & training records in one place

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Reports by norm, role & risk — export to PDF and CSV

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ISO 13485 quality plan, auto-built from your checklist gaps

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~8 hrs/month

Estimated time reclaimed per study by catching gaps early — illustrative, based on typical review cycles.

Pricing

Demo

Free

CRA / Site

€29/mo

Sponsor

€149/mo

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For CRAs

Walk into every monitoring visit already knowing the answer

No more digging through shared drives before a site visit. See SDV status, open deviations and overdue documents for every site, ranked by risk, the moment you log in.

For investigators & site staff

Know exactly what's missing — before the CRA has to tell you

Device accountability, AE/SAE logs, IP reconciliation and training records tracked against deadlines, with plain-language prompts for what to fix and by when.

Who we work with

The right partner for every regulatory challenge

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Medical device manufacturers

MDR 2017/745 compliance, CE marking, technical documentation, PMCF planning, and external PRRC support for Class I–III devices.

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Pharmaceutical sponsors

ICH E6 R2/R3 GCP compliance, clinical study protocols, CSRs, investigator brochures, and regulatory submissions to EMA.

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Clinical research teams

ISO 14155:2020 clinical investigations, CIP preparation, site monitoring support, audit readiness, and FDA BIMO inspection preparation.

Core services

End-to-end regulatory support

From device classification to post-market surveillance — SetuMed covers the full product lifecycle with precision and accountability.

01 — CLINICAL EVALUATION

Clinical evaluation

Clinical evaluation plan, strategy and CEAR
ISO 14155 study protocol (CIP)
Post-market clinical follow-up (PMCF)

02 — MEDICAL WRITING

Medical writing & project management

CSP/CIP, CSR, IB, ICF, IMPD
Peer-reviewed manuscripts, abstracts
SOPs, IFUs, QMS documentation

Insights

Short reads on staying compliant

Plain-language explainers on the standards and processes that shape a device or study's regulatory pathway.

ISO 14155:2026

What the 4th edition changes for sponsors

The new edition adds explicit CEC/DMC governance expectations and rules for decentralised elements like eConsent and remote monitoring — with no transition period from the 2020 version.

EU MDR / PMCF

What Notified Bodies look for in a PMCF report

A PMCF report needs to trace back to the clinical evaluation plan's objectives and show how post-market data confirms — or challenges — the device's safety and performance claims.

FDA BIMO

Preparing a site for a BIMO inspection

Inspectors typically start with informed consent documentation and source data verification — having a clean, cross-referenced essential documents file is the single biggest time-saver.

Regulatory compliance that catches gaps before they become backlog

Compliance that works as hard as your CRAs do

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