What services does Sathavahana Valiveti offer?

Sathavahana Valiveti offers Regulatory Pathway Assessment, Classification Assessment, Predicate Analysis, Test Strategy, 510(k) Authoring & Submission, De Novo & PMA Strategy and other regulatory consulting support depending on project needs.

What pathways does Sathavahana Valiveti support?

Sathavahana Valiveti supports 510(k), PMA, Q-Sub, Post-market and related FDA lifecycle activities.

What specialties does Sathavahana Valiveti work in?

Sathavahana Valiveti commonly supports IVD, Wearable Digital, Other device areas.

How much regulatory experience does Sathavahana Valiveti have?

Sathavahana Valiveti has 8+ years in regulatory and quality work.

Sathavahana Valiveti — 510(k) & PMA Consultant (IVD/Wearable Digital)

Q: What regions does Sathavahana Valiveti serve?

Regions served include: United States (FDA), European Union (MDR/IVDR), Canada (Health Canada), Asia-Pacific.

Senior Regulatory Affairs Specialist

Accomplished and driven Regulatory Affairs Specialist with over 8 years of comprehensive experience in navigating the complex landscape of medical device regulatory strategy. Dr. Valiveti possesses specialized expertise in Software as a Medical Device (SaMD), adeptly managing FDA 510(k) and PMA submissions, as well as EU MDR and IVDR compliance. Their collaborative approach with engineering teams ...

Experience: 8+ years

Submissions: 25 510(k), 5 De Novo, 10 PMA

Expertise & Specializations

Regulatory Pathways

510(k)PMAQ-SubPost-market

Device Specialties

IVDWearable DigitalOther

Regions Served

Sathavahana Valiveti provides regulatory consulting services to clients in:

United States (FDA)European Union (MDR/IVDR)Canada (Health Canada)Asia-Pacific

Credentials & Recognition

Education & Credentials

Possesses a strong academic foundation with an M.B.B.S. (MD) from Dr. NTR University of Health Sciences, complemented by an MS in Clinical Research and Pharmacovigilance from James Lind Institute. Further specialized training includes a Certificate of Regulatory Affairs and Quality Assurance from Duke University, equipping them with a robust understanding of medical device regulations and clinical research methodologies essential for navigating complex regulatory pathways.

Certifications

Certified Regulatory Affairs Specialist - US
Association of Regulatory and Clinical Scientists (ARCS)
2020

Professional Experience

A highly accomplished Senior Regulatory Affairs Specialist with over 8 years of dedicated experience in the medical device industry. Their career highlights include impactful roles at prominent organizations such as Medtronic, NuVasive – Globus Medical, and Thermo Fisher Scientific, where they consistently drove successful regulatory strategies. Proven expertise in securing global market approvals for a diverse range of medical devices, with a particular focus on Software as a Medical Device (SaMD) and AI-enabled technologies, demonstrating a strong ability to manage complex projects and deliver compliant solutions.

Former Big MedTech RA Leader
Enterprise experience

Executive Summary

Professional Overview

Core Specializations

Regulatory Pathways

510(k)PMAQ-SubPost-market

Device Specialties

IVDWearable DigitalOther

Services Offered

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

FDA Mock Audit
Pre-inspection preparation, mock FDA audits, and readiness assessments to ensure compliance before official FDA inspections.

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, EU, CA, APAC
Background: 8+ years of regulatory experience.

Cruxi view

With over 8 years of dedicated experience, Sathavahana Valiveti stands out as a formidable Regulatory Affairs Specialist with deep expertise in navigating the complex regulatory landscape for medical devices, particularly in the burgeoning field of Software as a Medical Device (SaMD) and AI/ML technologies. Their comprehensive experience spans critical FDA pathways, including successful 510(k) and PMA submissions, alongside adept management of EU MDR and IVDR compliance, making them exceptionally valuable for medtech companies targeting both US and European markets. Dr. Valiveti's proven track record in authoring pre-market submissions, managing post-market surveillance, and ensuring Ad-Promo compliance, coupled with their collaborative approach with engineering teams, significantly de-risks the product development lifecycle. Their strong foundation in QMS management and adherence to international standards like ISO 13485 and ISO 14971 further solidify their ability to drive efficient and compliant market access for innovative medtech solutions.

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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