We are Create ……. Expert, reliable, regulatory Affairs consultants for medical devices.
accelerate with regulatory augmented intelligence
What better way to accelerate by engaging an AI sidekick who never gets tired? Trained on MDR, IVDR, AI Act and FDA medical devices and IVD regulations and with top-notch data privacy so your information is safe. That’s what we call Regulatory Augmented Intelligence (RAI).
The RAI suite is at your disposal. Jump straight in with one of the buttons.
DINA LAKAYAN, Ph.D.
I started CREATE because often people choose to take two approaches when it comes to challenging tasks, either to wait? or to create!
CREATE is where I’ve seen a real difference can be made in regulatory strategy and implementation.
With a PhD in life sciences and nearly a decade of experience in regulatory affairs, I’ve supported market access for medical devices across the EU, US, and Canada. My approach combines scientific thinking with regulatory expertise to help companies respond effectively to changing regulatory frameworks .
I’m also the co-founder of ChatMDR, ChatIVDR, and ChatFDA- AI tools designed for regulatory compliance.
Driven by intellectual curiosity and a strong commitment to improving patient outcomes, I remain deeply dedicated to this field.
At CREATE, I’ve seen how strategy and science together can move healthcare innovation forward. I’m open to new challenges, and eager to CREATE with you.