About
Transforming regulatory requirements from compliance obligations into strategic business opportunities
Under Shay Leventhal-Gabay's leadership and with over three decades of specialized experience, we've developed a unique synchronization approach (Sync360) that aligns regulatory processes with business goals to significantly reduce time-to-market.
Our methodology engages all teams within your organization—
from R&D to creating a shared regulatory mindset that eliminates delays and prevents costly revisions. With a dedicated team of experts focused exclusively on medical device regulations across FDA, EU, and global markets,
we provide comprehensive regulatory guidance that delivers results.
Our clients and partners
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
Shai Novik
chairman Sharp Vision Inc
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
Penina Spetz
QA/RA/CA Director
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
Hen Nahum
COO, iPulse Medical
shai combines a solid understanding of regulatory frameworks with a pragmatic, hands-on approach that makes her support both effective and efficient
Ronen Castro
CEO, Acusurgical
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
Roxana Wagner
RA consultant
