Outcomes delivered
Trusted by the industry — the names you know already trust us
Value proposition
Deep regulatory expertise enhanced by proprietary AI.
Support from regulatory strategy and authoring through post-market maintenance.
Local intelligence across the US, UK, EU, and India.
Expertise, traceability, and quality built into every document.
Celegence offers two pricing options based on your stage in the EU MDR compliance journey: a first-time CER/CEP package for manufacturers requiring an initial deliverable, and a full maintenance plan for ongoing compliance and document upkeep. You can choose either option or combine both.
A one-time introductory rate for manufacturers preparing their first Clinical Evaluation Report or Clinical Evaluation Plan under EU MDR.
| Device classification | Unit price – CEP and CER |
|---|---|
| Class I | $6,100 |
| Class IIa | $7,750 |
| Class IIb | $9,050 |
| Class IIb Implantable | $10,900 |
| Class III | $12,400 |
Introductory pricing applies to first-time customers only. Contact us for custom quotes on complex devices or multi-device portfolios.
Once your initial CER/CEP is complete, our maintenance plans keep your documentation current, audit-ready, and aligned with evolving EU MDR requirements.
| Device classification | Unit price – CEP and CER |
|---|---|
| Class I | $4,600 |
| Class IIa | $5,850 |
| Class IIb | $6,750 |
| Class IIb Implantable | $8,250 |
| Class III | $9,650 |
Tell us about your device — we'll confirm scope and timeline.
"We don't reduce costs by replacing experts. We reduce costs by eliminating inefficiencies."
Traditional regulatory projects spend significant time and effort rebuilding context, repeating searches, recreating rationale, and reconstructing historical decisions. CAPTIS® preserves that knowledge in a structured environment. This allows our experts to focus on regulatory strategy, scientific evaluation, and compliance decisions rather than administrative rework.
The result is a more efficient delivery model that reduces cost while maintaining the quality, traceability, and expertise required for regulatory success.
Most AI companies sell software. Most consulting firms sell hours. Celegence delivers outcomes.
That combination allows us to provide first-time customers with an affordable entry point while maintaining the quality standards required for regulatory success.
The first-time customers price covers the complete CER and CEP deliverable, including the systematic literature review, clinical data analysis, and a final report ready for Notified Body submission.
First-time pricing covers your initial CER/CEP build. Full maintenance pricing covers the ongoing literature monitoring, data updates, and CER revisions needed to keep an existing report current under EU MDR.
Classification is based on your device's risk profile and intended use under EU MDR Annex VIII. Our team can confirm it with you before you commit to a package.
No — this is a permanent pricing option for first-time customers, not a limited-time promotion.
Yes. Combination products and multi-device portfolios are quoted individually — contact us for a tailored quote.
Most CERs are completed in an average of 6 weeks from kickoff, depending on device complexity and data availability.
Tell us about your device and we'll confirm pricing, scope, and timeline.
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