Sravanthi Polavarapu
Regulatory Affairs Expert - Medtech Compliance & Strategy
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.
HQ:
United States
Languages:
English
Claim status:
Claimed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 510(k) Strategy & Authoring, 510(k) RTA Remediation / Refuse-to-Accept Fix, Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C)
Pathways Supported:
Traditional 510(k), Pre-Sub / Q-Sub
Device Types Supported:
IVD, Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
5
Num510k Submitted:
1
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
Yes
Device Panels:
ivd, other
Technology Types:
ivd_test
Engagement Models:
hourly
Accepting New Clients:
No
