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.

Her work involved developing our complete regulatory approach and hands-on technical writing, creating detailed product documentation from the ground up to effectively communicate all product information to the FDA

What distinguishes Shay and her team is their ability to explain complex regulatory concepts into practical tasks, bringing order to our discussions and communicating at eye level using simple, understandable language that makes complex requirements accessible to everyone

Shai and her Team strategically guided the clinical aspects of our EU MDR compliance approach and created comprehensive documentation where insufficient information existed, filling in the gaps with professionalism and thoroughness

shai combines a solid understanding of regulatory frameworks with a pragmatic, hands-on approach that makes her support both effective and efficient

Shay operates at eye level, listens to my input, and considers my feedback as part of the process, creating a calm, non-pressured atmosphere while remaining focused and uncompromising

Shay dives deep into projects, bringing extensive experience, knowledge, and creative thinking to find rational solutions for our company's regulatory challenges.