Essentials of Medical Device Clinical Research

Meet your essential field guide to device trials: Essentials of Medical Device Clinical Research by Ashish Indani—a practical, end-to-end playbook built specifically for the realities of medical devices, not repurposed from drug trial lore. From global classifications and approval pathways to risk management, materiovigilance, data management, biostatistics, SaMD, and post-market evidence, this multi-volume set distills complex regulations and methods into clear, usable steps you can apply on Monday morning. If you work in device development, clinical investigation, RA/QA, or quality systems, this is the authoritative, operations-ready reference that bridges the gap between legacy pharma frameworks and the unique lifecycle of devices—helping you accelerate compliant studies, generate credible evidence, and get safe, effective technology to patients faster.