Implementation of design controls through Quality Management System

Over 250,000 Canadians suffer from epilepsy, a debilitating neurological condition with no known cure. For many patients, the only solution is the surgical removal of the seizure-trigger zones in the brain. Unfortunately, current electrode systems that are designed to record brain activity and target the seizure foci are highly invasive, not very precise, and do not provide adequate coverage of the brain to sufficiently isolate the target sites. This limits the standard of care for patients struggling with epilepsy, as healthy tissue may get extracted as the surgeon compensates for the lack of high-resolution mapping. To help address these gaps, Neuraura Biotech Inc. has developed novel electrode technology that provides 3 times higher resolution and 20 times more coverage of the brain. To facilitate the first clinical trials of this recording and 3D brain activity visualization system, quality control systems must be expanded and regulatory approvals must be obtained. The successful translation of this Canadian technology to serve both researchers and patients will require strong adherence to regulatory requirements and market analysis for commercialization. This quality management and strategy internship will equip the student with the skills needed to commercialize products, secure partnerships, attain regulatory approvals, and work in a multidisciplinary start-up environment, which will be key in their future aspirations in serving patients. The intern’s contributions to risk analysis, project management, and regulatory approval applications will help accelerate the organization’s commercialization timeline and help us serve both researchers and patients with higher-quality devices for the treatment of neurological disorders.

Faculty Supervisor:

Naweed I. Syed

Student:

Partner:

Neuraura

Discipline:

Life Sciences

Sector:

Manufacturing

University:

University of Calgary

Program: