AI Diagnostic Imaging Analysis SaaS Module -- EU MDR Class IIa Software as Medical Device Development

Curated by Vinod Kumar Jain & Amit Jain · All Frontier Global · free, no login

Corridor

Germany-India

Mandate Type

buy

Principal Type

buyer

Incoterm

Fixed price milestones plus T+M maintenance

Price Range

EUR 580,000-820,000 for full development to CE marking 18-24 months; EUR 80,000-120,000 per year maintenance

Payment Terms

Milestone-based billing; 10% retention on each milestone

Frequency

project-based plus maintenance

Specification

AI model for chest X-ray analysis -- pneumonia TB COVID nodule detection; EU MDR 2017/745 SaMD Class IIa Notified Body mandatory; IEC 62304 software lifecycle compliance; IEC 62366 usability engineering; ISO 14971 risk management; AUC minimum 0.92 per pathology class; Grad-CAM explainability; GDPR patient data pseudonymised; AWS EU Ireland deployment; DICOM-compatible API output

Notes

German imaging company: EUR 28M revenue; 3 FDA-cleared US products. Entering EU with CE MDR SaMD. First milestone: 6-month paid POC EUR 120,000 with 3 pathology classes. NDA and IP assignment required. Indian team works in German time zone overlap.

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