What services does Seshasena Reddy Muli offer?

Seshasena Reddy Muli offers Regulatory Pathway Assessment, 510(k) Submission Authoring, De Novo & PMA Strategy, QMS Setup & Implementation and other FDA regulatory consulting services for medical device companies.

What regulatory pathways does Seshasena Reddy Muli specialize in?

Seshasena Reddy Muli specializes in 510k, Pma, Ide and other FDA regulatory pathways for medical devices.

What is Seshasena Reddy Muli's regulatory experience?

Seshasena Reddy Muli has 2+ years of experience in FDA regulatory affairs.

Seshasena Reddy Muli

Quality Analyst & Regulatory Coordinator

A highly motivated regulatory and quality professional with a Master of Science in Regulatory Affairs from Northeastern University (GPA 4.0) and a clinical background as a Doctor of Pharmacy. Possesses hands-on experience in developing comprehensive regulatory strategies for Class II medical devices, from concept through to FDA submission, and authoring regulatory pathways for international market...

Experience: 2+ years

Expertise & Specializations

Regulatory Pathways

510kPmaIde

Device Specialties

OrthopedicObgynGeneral Surgery

Regions Served

Seshasena Reddy Muli provides regulatory consulting services to clients in:

United States (FDA)Canada (Health Canada)

Credentials & Recognition

Certifications

Licensed Pharmacy Trainee Technician
Massachusetts Board of Registration in Pharmacy

GCP for Clinical Trials with Investigational Drugs and Medical Devices
Northeastern University
2025

CPR, BLS, AED Certification
National Health & Safety Association

Executive Summary

Professional Overview

Core Specializations

Regulatory Pathways

510kPmaIde

Device Specialties

OrthopedicObgynGeneral Surgery

Services Offered

ISO 13485 Consulting
Quality management system development, gap analysis, and ISO 13485 certification support for medical device manufacturers.

ISO 14971 Consulting
Risk management system development, risk analysis, and ISO 14971 compliance support for medical device risk management.

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.

QMS Setup & Implementation
Quality management system design, implementation, and validation to meet FDA and ISO requirements.

Post-Market Support
Post-market surveillance, adverse event reporting, and ongoing regulatory compliance support.

Cruxi Independent Snapshot

Best suited for

• MedTech companies seeking expert regulatory guidance

Experience signals

Regions: US, CA
Background: 2+ years of regulatory experience.

Cruxi view

Seshasena Reddy Muli offers a powerful combination of elite academic training and targeted hands-on experience ideal for medtech innovators. With a Master's in Regulatory Affairs (4.0 GPA) from Northeastern and a clinical Doctor of Pharmacy background, they possess a rare, dual perspective on product development. Their 2 years of focused experience have been spent developing comprehensive regulatory strategies for Class II medical devices, including authoring pathways for both the US FDA and Health Canada. This consultant excels in building regulatory compliance from the ground up, with deep expertise in QMS (21 CFR 820, ISO 13485), risk management (ISO 14971), and authoring 510(k) submission strategies, making them an exceptionally sharp and valuable asset for navigating the crucial early stages of market access.

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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