Medical imaging AI: validation methodology, external validation studies and regulatory-grade evidence (MDR / TITCK)

We are an Istanbul-based medtech SME. We develop and validate medical imaging AI ourselves: our segmentation models are externally validated, our methods are published in peer-reviewed journals, and our platform is in clinical use in four countries. We bring this hands-on methodology into consortia as a partner.

What we contribute:

• External and multicenter validation: study design, locked test sets, reader studies, inter-observer reliability (ICC), statistical analysis plans and execution

• Reporting and evidence: CLAIM 2024 and TRIPOD+AI compliant design and reporting, regulatory-grade evidence aligned with EU MDR and Turkish (TITCK) pathways

• Reference standards: annotation protocol design, expert reading workflows, multicenter data curation, anonymization at source (GDPR/KVKK)

• Independent evaluation: benchmarking and performance audits of imaging AI models, robustness and degradation analysis

What we are looking for:

• Validation or methodology partner roles, or a validation work package lead, in Horizon Europe and Eurostars consortia working on medical imaging and AI-based health technologies

• As a Turkish SME, we bring our own national funding channel (TUBITAK) into Eurostars and Horizon projects, reducing the budget burden on other partners

Languages: English, Turkish. Remote-first, EU-timezone friendly.