Ester Carrasco, MEng

Ester is a medical device regulatory and quality management compliance specialist. She supports clients with agile quality management systems implementation, with a special focus on start-up companies that require significant support and training. She has experience with many key aspects of quality management, including document and design controls, design transfer, supplier controls, management reviews, and internal audits. She has also prepared design dossiers and has previous design experience with a range of medical devices, developing product features, identifying required testing, and preparing user documentation.

Ester is also an experienced regulatory researcher supporting regulatory strategy for platform technologies and preparing regulatory submissions, including FDA 510(k) Submissions, Pre-submissions (Q-Subs), De Novo, and Breakthrough Device Designation Requests.