Developed and tested, software modules for ImaTx OsDx bone densitometer, for assessment of osteoporosis from radiographic images, resulting in FDA clearance of the device. Software features developed include automated calibration, regions of interest placement, density measurements, bone feature extraction for use in a disease detection and risk assessment model. Also involved in the design of calibration apparatus, accessories, and protocol for radiographic imaging. Managed and executed data analysis contracts: Radiograph digitization, image processing, data compilation, and statistical analyses. Designed GUI with special emphasis on visual clarity and simplicity. Developed user's and training manuals. Applied data modeling methods for prediction and estimation. Experienced in documentation satisfying the ISO13485 design control and document control requirements. Includes: Product Specification, Software Requirements, UML class diagrams, Validation and Verification Protocols, Hazard Analysis, Failure Mode and Effects Analysis. Familiar with FDA guidelines for medical devices requirements, and specifically for bone densitometer and sonometer for 510(k) and Pre-market Approval, i.e., class level analysis, clinical trial criterion, statistical methods, verification & validation requirements.
