For nearly three years, Shay has played a key role in maintaining our quality management system and overseeing all regulatory activities, making a meaningful impact on our daily operations and long-term compliance. She manages communication with subcontractors, updates labeling and DHF/DMR documentation, and leads our Notified Body audits hands-on with great professionalism.
This year, our 5-day ISO 13485 and EU MDR recertification audit passed smoothly. At the closing meeting, the auditor remarked: “Well done for managing all these items with such a small team—it's really impressive.”
In parallel, Shay has driven significant progress in expanding our product indications for entry into new markets. She developed a regulatory strategy fully aligned with the business plan, helping expedite our time to market while ensuring that all requirements are met proactively and efficiently.
Shay brings dedication, expertise, and a calm, solutions-oriented approach to every task. Her work ensures smooth regulatory processes, continued alignment with FDA, EU MDR, and ISO 13485 requirements, and provides us with real peace of mind knowing these critical areas are being managed with care and competence.