Our Berlin medical imaging AI development follows the regulatory-first principle: every project is designed from day one for EU MDR compliance and clinical validation. Software classification under MDR: imaging AI that provides diagnostic support (e.g., "suspicious lesion detected, recommend further investigation") is typically classified as Class IIa medical device software (SaMD). This requires: quality management system per ISO 13485, risk management per ISO 14971, software lifecycle per IEC 62304, clinical evaluation per MEDDEV 2.7/1, and a CE marking process involving a Notified Body (like TÜV or BSI). We build the technical infrastructure and documentation in parallel with the software development — not as an afterthought. Technical approach for radiology AI: (1) Data pipeline: DICOM images from the hospital PACS (Picture Archiving and Communication System) are anonymized and processed through our training pipeline. We work with the clinical team to curate labeled datasets — radiologist-annotated studies with confirmed diagnoses. (2) Model architecture: depending on the imaging task, we use convolutional neural networks (for 2D imaging like mammography and X-ray), 3D CNNs or transformer architectures (for volumetric CT and MRI data), and detection/segmentation models (for localizing specific findings). (3) Clinical integration: the AI model runs as a DICOM-compatible service that integrates with the hospital's PACS and RIS (Radiology Information System). A study arrives in PACS → the AI analyzes it → results are posted back as a DICOM Structured Report or as annotations on the images → the radiologist sees the AI findings alongside the study during their normal reading workflow. No separate platform or additional clicks required. For digital pathology: whole slide images (WSI) from digital scanners (Hamamatsu, Leica Aperio, 3DHISTECH) are processed by tissue-specific AI models. Pathology AI can: detect and grade tumors (breast cancer grading, prostate Gleason scoring), count mitotic figures, identify lymph node metastases, and quantify biomarker expression (Ki-67, PD-L1) — tasks that are tedious, time-consuming, and subject to inter-observer variability when done manually.