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
Certifications
Association of Regulatory and Clinical Scientists (ARCS)
2020
Professional Experience
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
With 8 years of experience, Dr. Sathavahana Valiveti specializes in navigating the complexities of medical device regulatory strategy, particularly in Software as a Medical Device (SaMD). Their extensive expertise in managing FDA 510(k) and PMA submissions, along with compliance for EU MDR and IVDR, positions them as a formidable force in the medtech landscape. Dr. Valiveti boasts a robust track record, having successfully authored 25 510(k) submissions and 10 PMAs, demonstrating their technical competencies and deep understanding of regulatory pathways. Their collaborative approach with engineering teams enhances the efficiency of regulatory strategies for AI-enabled and cloud-native medical software, making them a vital asset for any medtech company aiming to innovate and achieve market compliance efficiently.
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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