From Concept to Clinic: Pre-Clinical Testing and Regulatory Considerations in Spine Implant Development.

Abstract

Spinal implant development demands integration of biomechanical rigor with regulatory compliance. For surgeons, researchers, and biomedical engineers engaged in translational research, understanding the regulatory pathway, from the This paper reviews the major regulatory frameworks governing spinal implants, including the Key elements of the regulatory process include design controls and documentation (DHF/technical file), Understanding the biomechanical foundations of the development process