Golnaz Moeini

Regulatory Consultant @ iSono Health

About Golnaz Moeini

Golnaz Moeini Regulatory Consultant

Golnaz Moeini is a regulatory consultant with extensive experience in the medical device and digital health sectors. Her career includes senior positions at multiple companies within the industry, where she has been instrumental in guiding regulatory strategies and ensuring compliance with applicable regulations.

Experience with Artery, Avinger, Stryker, and Cardinal Health

Golnaz Moeini has held senior positions at prominent companies such as Artery, Avinger, Stryker, and Cardinal Health. Her roles at these organizations have provided her with a broad understanding of the regulatory landscapes for both startup and large-scale companies, particularly in the medical device and digital health fields.

Developed Regulatory Strategy

In her capacity as a regulatory consultant, Golnaz Moeini has developed comprehensive regulatory strategies for various medical devices and digital health products. Her expertise ensures that these products meet the necessary regulatory standards and can navigate the complexities of regulatory environments effectively.

Obtained 510(k) Clearances and PMA Approval

Golnaz Moeini's proficiency extends to obtaining critical regulatory approvals, including 510(k) clearances and Premarket Approval (PMA) from regulatory authorities. Her skill in securing these approvals underscores her deep knowledge of regulatory requirements and her ability to successfully bring medical devices to market.

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