What services does Gayathri Manoj offer?

Gayathri Manoj offers Regulatory Pathway Assessment, 510(k) Submission Authoring, De Novo & PMA Strategy and other FDA regulatory consulting services for medical device companies.

What regulatory pathways does Gayathri Manoj specialize in?

Gayathri Manoj specializes in 510k, De Novo and other FDA regulatory pathways for medical devices.

What is Gayathri Manoj's regulatory experience?

Gayathri Manoj has 4+ years of experience in FDA regulatory affairs.

Gayathri Manoj

Regulatory Affairs Professional

Gayathri Manoj is a regulatory affairs professional with over 4 years of experience in biologics, medical devices, and the clinical space. She possesses a proven track record across a diverse range of submissions and strategies, including 510(k), De Novo, and Breakthrough designations, as well as Common Technical Documents (CTDs).

Experience: 4+ years

Expertise & Specializations

Regulatory Pathways

510kDe Novo

Executive Summary

Professional Overview

Core Specializations

Regulatory Pathways

510kDe Novo

Services Offered

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

510(k) Authoring & Submission
Complete 510(k) submission preparation, documentation authoring, and FDA submission management.

De Novo & PMA Strategy
Strategic planning and support for De Novo and PMA pathways, including clinical trial design and FDA meeting preparation.

Cruxi Independent Snapshot

Best suited for

• MedTech companies seeking expert regulatory guidance

Experience signals

Background: 4+ years of regulatory experience.

Cruxi view

Gayathri Manoj offers a focused regulatory affairs skillset, particularly valuable for smaller companies navigating the complexities of early-stage medical device submissions. With 4+ years of experience, her expertise spans biologics, medical devices, and clinical trials, with a strong emphasis on 510(k) traditional and De Novo pathways. Her experience with orthopedic, dental, radiology, and software as a medical device (SaMD) provides a diverse background. This combination makes her well-suited for companies seeking efficient and cost-effective support for Class I and II device submissions.

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

Contact Gayathri Manoj

Share a brief overview of your device and timeline. Cruxi will forward your request to Gayathri Manoj and help structure next steps.

Contact Now