Beyond Compliance:
Medea™ Saves Your CRO €30.000+ Every Year
Medea™ is not just a regulatory safeguard. It is a measurable financial advantage — reducing the time your compliance team spends on every Clinical Evaluation Report by up to 70% on the most labour-intensive activities.
How We Built the Model
MODEL PARAMETERS
Each Clinical Evaluation Report (CER) requires an average of 120 hours of work by a CRO or Medical Device compliance team (actual time varies by device class and complexity). Of this total, approximately 35% — i.e. 42 hours per CER — is dedicated to the research-intensive phase: systematic literature review, evidence appraisal, risk-benefit analysis, and technical annexes. This is precisely where Medea™ intervenes with the greatest impact. The remaining 65% (78 hours) is spent drafting and customising the CER narrative according to company-specific guidelines.
CER Time Allocation — 120 Hours Total
Medea™ reduces the research phase time by 70%, cutting 42 hours down to just 12,6 hours per CER — saving 29,4 hours of high-value compliance work on every single report.
-70%
Research Phase Time
From Hours Saved to Net Annual Saving?
1 - Research Phase
Hours Dedicated to Research per CER
120 total hours × 35% = research-intensive activities (literature review, evidence appraisal, risk-benefit analysis, technical annexes)
42 hrs
per CER
2 - Medea® Time Saving
Hours Saved per CER with Medea
Medea automates and accelerates 70% of the research phase: 42 hrs × 70% = hours recovered per CER, available for higher-value activities
29,4 hrs
saved per CER
3 - Gross Saving per CER
Labour Cost Saving per CER
29,4 hrs × €40/hr (exitimated average compliance specialist hourly rate) = gross monetary saving on each CER produced with Medea
€1.176
gross per CER
4 - Monthly Volume (Baseline)
Gross Monthly Saving (2 CERs/month)
A CRO producing 2 CERs per month — a conservative baseline for an active regulatory team — generates: €1.176 × 2 = gross monthly labour saving
€2.352
gross /month
5 - Net Saving After Licence
Net Monthly Saving After Medea Licence
Calculated after accounting for the monthly Medea subscription = net saving retained by the CRO each month
€1.362
net /month
€1.362
Net Monthly Saving
x 12
Months per Year
= €16.344
Minimum Net Annual Saving per CRO
Bottom Line — Net Annual ROI
Every CRO Using Medea™ Saves a Minimum of €16.344 per Year
This is a conservative baseline estimate, calculated on just 2 CERs per month. CROs with higher CER volumes, more complex devices, or higher hourly labour rates will realise proportionally greater savings. The licence cost is recovered within the first month of operation.
€16.344
minimum net saving / year
The More CERs You Produce, the Greater the Return
Baseline CRO
€16.344
2 CERs/month
Net saving after licence
= €1.362/month × 12
Mid-Size CRO
€44.568
4 CERs/month
Net saving after licence
= €3.714/month × 12
Large CRO
€72.792
6 CERs/month
Net saving after licence
= €6.066/month × 12
Two Dimensions of Value — One Platform
Regulatory Protection
Structural MDR Compliance Safeguard
- Traceable & Auditable Literature Reviews: Flawless automated parsing across MEDLINE/PubMed and Embase eliminates systematic evidence gaps.
- EU MDR Annex XIV-Aligned: Built natively around the precise structures required by European regulators.
- Liability & Asset Shielding: Protects your organization against severe documentation fines of up to €140.000.
- Permanent Audit Readiness: Transforms technical files from a recurring corporate emergency into a continuous, standard operational state
Financial Return
Measurable Cost Saving from Day One
€16,344+ Minimum Net Annual Saving (Baseline)
- Linear Scale-Up Economy: Your operational software cost stays fixed while your returns scale with your volume.
- Day-One Labor Savings: Immediate reduction of up to 70% in the core research timelines per technical file.
- Instant Cost Recovery: The full platform license is offset within the very first month of deployment.
- Capacity Optimization: Frees your regulatory and clinical experts from administrative fatigue, allowing them to focus on high-impact activities.
Start Saving €16K+ from Month One
Join the exclusive Medea™ Early Adopter Program before our formal launch. Secure founding partner rates and start building an audit-proof portfolio.
Official launch: June 21, 2026.