Sathavahana Valiveti — 510(k) & PMA Consultant (IVD/Wearable Digital)
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
Device Specialties
Regions Served
Sathavahana Valiveti provides regulatory consulting services to clients in:
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
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.
Enterprise experience
Executive Summary
Professional Overview
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 subm...
Core Specializations
Regulatory Pathways
Device Specialties
Services Offered
Quality management system development, gap analysis, and ISO 13485 certification support for medical device manufacturers.
Pre-inspection preparation, mock FDA audits, and readiness assessments to ensure compliance before official FDA inspections.
Risk management system development, risk analysis, and ISO 14971 compliance support for medical device risk management.
Strategic assessment to determine the appropriate FDA regulatory pathway (510(k), De Novo, PMA) for your medical device.
Complete 510(k) submission preparation, documentation authoring, and FDA submission management.
Strategic planning and support for De Novo and PMA pathways, including clinical trial design and FDA meeting preparation.
Quality management system design, implementation, and validation to meet FDA and ISO requirements.
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
Dr. Valiveti offers a rare and powerful combination of a clinical background (M.D.) and over 8 years of specialized medtech regulatory experience honed at industry leaders like Medtronic. Their expertise is exceptionally strong in the high-growth area of Software as a Medical Device (SaMD) and AI/ML technologies, backed by a proven track record of over 25 successful 510(k) submissions and 10 PMAs. This unique blend of clinical insight and deep regulatory knowledge allows them to develop robust strategies for complex digital health products across both US (FDA) and EU (MDR/IVDR) markets. For medtech companies, this translates into a strategic partner who can de-risk product development, streamline submissions, and accelerate global market access for innovative technologies.
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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