Ankita Singh

@Elaya Inc

Assisted in preparing regulatory submission documentation for FDA 510(k) and Health Canada MDL applications.Conducted regulatory gap analyses comparing product documentation to FDA and Health Canada requirements.Supported quality management system (QMS) alignment with ISO 13485 standards.Researched and compiled market authorization pathways for Class II medical devices in North America.Collaborated with cross-functional teams to ensure documentation compliance for design, manufacturing, and post-market requirements.