Sathavahana Valiveti
Expert SaMD & AI/ML Regulatory Strategist | FDA 510(k), PMA, EU MDR/IVDR | 8+ Years Experience
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 ensures robust regulatory strategies for AI-enabled and cloud-native medical software, from initial development through post-market surveillance. With a proven track record of authoring critical pre-market submissions and post-market documentation for global market access, and a keen eye for Ad-Promo review and QMS management, Dr. Valiveti is a valuable asset for any medtech company seeking to bring innovative solutions to market efficiently and compliantly.
HQ:
United States
Languages:
English
Claim status:
Claimed
Services & Capabilities
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Pricing model:
Custom pricing
Services Offered:
Regulatory Pathway Assessment, 510(k) Strategy & Authoring, 510(k) eSTAR Preparation, Device Classification Support, Special 510(k) Support, Traditional 510(k) Support, Predicate Research & Substantial Equivalence Strategy, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C), Labeling Review for Submission (510(k)/De Novo/PMA), Submission Project Management (end-to-end)
Device Types Supported:
Medical device, IVD, SaMD
Supports Estar:
No
Supports Rta Remediation:
No
Supports Predicate Research:
No
Supports Labeling Review:
No
Provides Submission Project Management:
No
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
Yes
Accepting New Clients:
Yes
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