Andrei Blaj - Atta Systems Blog

MedTech MedTech Product Development: From Concept to Regulatory Clearance MedTech product development is the regulated process of designing, engineering, verifying, validating, and submitting a medical device or device software for market clearance under FDA design controls, EU MDR requirements, or both. The medical device product development lifecycle spans six... By Andrei Blaj Jun 18, 2026

MedTech MedTech Software Development: Standards, Tech Stack, and Partner Selection MedTech software development is the process of building software for medical devices, clinical platforms, and digital health systems, subject to regulatory frameworks such as IEC 62304, ISO 13485, and the FDA Software as a Medical Device (SaMD) classification. The wrong... By Andrei Blaj Jun 4, 2026

MedTech AI in MedTech: Applications, Regulatory Requirements, and Case Studies AI in MedTech is the application of machine learning and deep learning algorithms to regulated medical technology—medical imaging, drug development, surgical robotics, remote patient monitoring, electronic health records, predictive analytics, and fraud detection—operating under FDA design controls, EU MDR, and... By Andrei Blaj Apr 29, 2026