Medical AI Guides
In-depth Medical AI guides for research, medtech and medical-AI teams. Methodical, sourced and defensible practice.
11 articles
Medical AI
How to Write the Statistics Section of a Clinical Evaluation Report (CER)
How to write the CER statistical core: MEDDEV 2.7/1 Rev 4, EU-MDR Annex XIV, and the biostatistician's role in state-of-the-art appraisal and data synthesis. It is not a QMS document, it is a clinical evidence analysis.
June 30, 2026 · 8 min read
Medical AI
EU AI Act Article 10: Data Governance and Representativeness in Medical AI
EU AI Act Article 10 defines data governance, dataset representativeness, and bias obligations for high-risk medical AI. A subgroup analysis and data quality plan ahead of the August 2026 entry into force.
June 30, 2026 · 8 min read
Medical AI
RWE (Real-World Evidence) Medical-AI Protocol
Real-world evidence (RWE) for medical AI: study design, protocol, SAP, confounding and bias control, the FDA RWE guidance (December 2025), and how to set up post-market surveillance.
June 30, 2026 · 9 min read
Medical AI
MRMC Multi-Reader Study: Proving AI Diagnostic Performance
Proving AI diagnostic performance with an MRMC multi-reader multi-case study: ROC/AUC, reader variability, AI-vs-reader, AI-assisted reading, and FDA expectations.
June 30, 2026 · 9 min read
Medical AI
Is Our SaMD Class IIa or IIb? Software Medical Device Classification
Medical-AI / SaMD Class IIa or IIb? How MDR Annex VIII Rule 11, MDCG 2019-11, and the intended use statement determine the class: the surgical intervention and serious deterioration fault lines, a classification decision guide.
June 30, 2026 · 6 min read
Medical AI
How to Design a SaMD Clinical Validation Study
How to design a SaMD clinical validation study: standalone performance, study design, sample size, AUC-ROC, reference standard, internal vs external validation guide.
June 30, 2026 · 9 min read
Medical AI
How to Prepare a TITCK CDSS Clinical Validation Report
What a TITCK CDSS/SaMD clinical validation report must contain and who prepares it: EU-MDR transposition, standalone performance, training-data representativeness, risk management, and the statistical core.
June 30, 2026 · 8 min read
Medical AI
TRIPOD-AI and PROBAST-AI: Reporting AI Diagnostic Models
How to report an AI diagnostic/prognostic model with TRIPOD-AI, how to assess risk-of-bias with PROBAST-AI, and the common gaps that reviewers and regulators look for.
June 30, 2026 · 8 min read
Medical AI
Data Leakage and Train-Test-Split Errors in AI Validation
How data leakage and train-test-split errors sink a medical AI validation file: patient-level split, external validation, and the FDA independent-test expectation.
June 30, 2026 · 8 min read
Medical AI
Clinical AI Validation Pipeline: TRIPOD/DECIDE-AI
The path of medical AI models to clinical use: internal validation, external validation, prospective deployment study, TRIPOD-AI 2024 + DECIDE-AI reporting, ROC vs decision curve analysis, calibration, ethics committee requirements, and the TITCK SaMD process.
May 26, 2026 · 9 min read
Medical AI
Artificial Intelligence in Radiology: nnU-Net Segmentation
For teams that want to develop an AI model in medical imaging: the nnU-Net architecture, the 2D vs 3D decision matrix, transfer learning, validation strategy, TRIPOD-AI compliant reporting, and a clinical validation roadmap. A practical technical guide for medical artificial intelligence.
May 23, 2026 · 10 min read