Cordelia Ashmore, Senior Medical Device Software Engineer

Cordelia Ashmore, PhD

SENIOR MEDICAL DEVICE SOFTWARE ENGINEER

Joined: September 7, 2026

Summary

I have supported five FDA 510(k) submissions, leading and submitting one, while overseeing design controls, verification and validation, and design and development, and managing an ISO 13485 quality system for clinical medical device software. I also develop the software, in Python, C++, and LabVIEW. My background is a PhD in Neuroscience and a Master's in Computer Science, with sixteen years in medical devices. That experience includes brain-computer interface systems and clinical devices for oculomotor, vestibular, and brain health assessment. I was lead developer and project manager on the FDA-cleared VEST platform, where I led pre-submission and other FDA interaction meetings. I am co-inventor on four US patents in neurological assessment and rehabilitation and co-author of thirteen peer-reviewed articles plus two reviews and book chapters. At Innolitics I help clients take software-driven devices from design input through verification, regulatory assessment and documentation, and submission.

Skills

SaMD Development Medical Device Regulation LabVIEW Python Eye-tracking Neural Electrophysiology

Bio

I hold a PhD in Neuroscience and a Masters in Computer Science and have spent 16 years working in medical devices, particularly devices for brain-computer-interface systems and clinical devices for doing oculomotor, vestibular, and brain health assessment. At Neuro Kinetics (later Neurolign, then Spryson) I became lead developer and project manager for the VEST clinical platform, part of a suite of FDA-cleared tools for video nystagmography. During that time I oversaw design controls, verification and validation, and design and development processes. I also became manager of the company’s ISO 13485 quality system, and led pre-submission and other interaction meetings with FDA. I led and submitted a 510(k) update that cleared new features for the platform (K181025), and significantly contributed to four other submissions. I have done professional development in multiple languages including C++, LabVIEW, and Python. As part of this work I have been co-inventor on four US patents in neurological assessment and rehabilitation technology and co-author of thirteen peer-reviewed research articles plus two reviews and book chapters, spanning brain-computer interfaces, oculomotor testing, vocal production, and concussion. At Innolitics I help clients take software-driven devices from design input through verification, regulatory assessment and documentation, and submission.

Hobbies

Music composition, Role-playing games (D&D), Digital art and 3D modeling, Bowling