DP

DEMET (DEE) GRACE SAG, PhD — 510(k) & PMA Consultant (Cardiovascular/IVD)

Director | Vice President

Translational medicine and regulatory science executive with over 15 years of experience leading end-to-end product lifecycles from discovery to market access. PhD in Molecular Genetics and Stem Cell Developmental Biology with deep expertise in integrating science, clinical development, and regulatory strategy across diverse settings. Proven ability to lead cross-functional teams and drive complex...

Experience: 22+ years

Expertise & Specializations

Regulatory Pathways

510(k)PMAIDEQ-SubPost-market

Device Specialties

CardiovascularIVDOther

Credentials & Recognition

Certifications

OTHER
OTHER

Executive Summary

Professional Overview

Translational medicine and regulatory science executive with over 15 years of experience leading end-to-end product lifecycles from discovery to market access. PhD in Molecular Genetics and Stem Cell Developmental Biology with deep expertise in integrating science, clinical development, and regulato...

Core Specializations

Regulatory Pathways

510(k)PMAIDEQ-SubPost-market

Device Specialties

CardiovascularIVDOther

Services Offered

Regulatory Pathway Assessment
Strategic assessment to determine the appropriate FDA regulatory pathway (510(k), De Novo, PMA) for your medical device.

Cruxi Independent Snapshot

Best suited for

  • • MedTech companies seeking expert regulatory guidance

Experience signals

  • Background: 22+ years of regulatory experience.

Cruxi view

Demet (Dee) Grace Sag, PhD, offers a unique blend of 22 years of experience, deep regulatory expertise, and extensive FDA experience, making her a valuable asset for medtech companies. With a strong background in translational medicine and regulatory science, she has led end-to-end product lifecycles from discovery to market access. Her expertise spans oncology, cardiovascular, regenerative medicine, and precision diagnostics, and she has extensive experience with regulatory strategy and medical writing for various devices and IVDs. Her proven ability to lead cross-functional teams and drive complex programs is particularly valuable for medtech companies navigating the complex regulatory landscape. Her unique combination of scientific expertise, regulatory knowledge, and leadership skills makes her an exceptional choice for medtech professionals seeking guidance on FDA submissions, regulatory strategy, and medical writing.

This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.

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