Seshasena Reddy Muli
Regulatory Affairs & Quality Specialist for Medical Devices. Expertise in FDA/Health Canada submissions, QMS (ISO...
A highly motivated regulatory and quality professional with a Master of Science in Regulatory Affairs from Northeastern University (GPA 4.0) and a clinical background as a Doctor of Pharmacy. Possesses hands-on experience in developing comprehensive regulatory strategies for Class II medical devices, from concept through to FDA submission, and authoring regulatory pathways for international markets like Canada. Expertise includes in-depth knowledge of FDA regulations (21 CFR 820), cGMP, Quality System Regulation (QSR), and international standards such as ISO 13485 and ISO 14971. Proven ability in Quality Assurance, including CAPA management, change control, and SOP authoring. Combines rigorous academic training with practical experience in cross-functional collaboration, making them a valuable asset for medtech companies seeking efficient and compliant market access.
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, Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, PMA Strategy & Support
Pathways Supported:
Traditional 510(k), PMA
Device Types Supported:
Medical device
Supports Predicate Research:
Yes
Years Experience:
2
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
orthopedic, obgyn, general_surgery
Technology Types:
wearable_patch, combo_product
Accepting New Clients:
Yes
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