Leah Applewhite
20-Year Medtech Quality & Regulatory Executive | Medical Device & IVD Expert
Leah Applewhite is a seasoned Quality & Regulatory executive with 20 years of experience, bringing extensive expertise in Medical Device and In-Vitro Diagnostic (IVD) Devices. She has a proven track record in creating and implementing robust quality management systems, leading critical compliance initiatives, and providing expert regulatory consulting services. Leah is dedicated to ensuring regulatory success and fostering operational excellence for her clients.
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, Predicate Research & Substantial Equivalence Strategy
Pathways Supported:
Traditional 510(k), De Novo
Device Types Supported:
IVD, SaMD, Medical device
Supports Predicate Research:
Yes
Years Experience:
17
Num510k Submitted:
25
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
Yes
Device Panels:
cardiovascular, neurology, radiology, dental, general_surgery, wearable_digital, ivd
Technology Types:
samd, implantable, wearable_patch, combo_product, ivd_test
Accepting New Clients:
No
