What services does Sravanthi Polavarapu offer?

Sravanthi Polavarapu 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 Sravanthi Polavarapu specialize in?

Sravanthi Polavarapu specializes in 510k, Q Sub, Post Market and other FDA regulatory pathways for medical devices.

What is Sravanthi Polavarapu's regulatory experience?

Sravanthi Polavarapu has 5+ years of experience, 1+ 510(k) submissions in FDA regulatory affairs.

Sravanthi Polavarapu

Regulatory Affairs Specialist

Regulatory affairs expert with experience in FDA submissions, medical device compliance, and global regulatory strategies. Skilled in QMS, ISO 13485, and quality systems. Proven track record of success in navigating complex regulatory landscapes and driving business growth. Contact for quote for comprehensive regulatory services.

Experience: 5+ years

Submissions: 1 510(k)

Expertise & Specializations

Regulatory Pathways

510kQ SubPost Market

Device Specialties

IvdOther

Regions Served

Sravanthi Polavarapu provides regulatory consulting services to clients in:

United States (FDA)Canada (Health Canada)

Credentials & Recognition

Professional Experience

Former Big MedTech RA Leader
Enterprise experience

Executive Summary

Professional Overview

Core Specializations

Regulatory Pathways

510kQ SubPost Market

Device Specialties

IvdOther

Services Offered

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

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: 5+ years of regulatory experience.

Cruxi view

Sravanthi Polavarapu offers a potent combination of specialized expertise and big-medtech experience, making her an invaluable asset for diagnostic companies. With 5 years focused on the IVD space, her background at Siemens Healthineers provides deep insight into navigating complex quality systems and product development lifecycles. Her proven track record, including managing multiple FDA pre-submissions and successfully achieving Health Canada clearance for Class II assays, demonstrates a clear ability to execute on critical regulatory milestones. This practical success, underpinned by a specialized Master's degree in Regulatory Affairs from Johns Hopkins, makes her a highly strategic partner for medtech companies seeking to navigate the FDA's 510(k) pathway and enter the North American market.

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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