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.
About
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.
Additional information
### **Additional information**
- **Type:** independent
- **Years of experience:** 17
- **510(k)s submitted (self-reported):** 25
- **Ex-Big MedTech:** Yes
- **Regions served:** US, CA, EU
- **Client types:** startup, sme, large_medtech
- **Location:** United States (California)
- **Availability:** available_now
- **Certifications:** Project Management Professional, Certified Quality Engineer, Medical Device Auditor
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### **Cruxi analysis**
- **Strength summary:** With 20 years of executive-level experience and a background in large medtech, Leah Applewhite offers a rare and powerful combination of high-level regulatory strategy and deep quality systems architecture. Her proven track record, including guiding 25 510(k) and 5 De Novo submissions, demonstrates a profound understanding of complex FDA pathways. This expertise is complemented by an exceptional proficiency in building and implementing robust, audit-ready Quality Management Systems, validated by her certifications as a Certified Quality Engineer (CQE) and Medical Device Lead Auditor. For medtech companies, Leah provides a holistic partnership, ensuring not only successful market entry for complex devices like cardiovascular, IVD, and SaMD, but also establishing the foundational compliance and operational excellence required for long-term success.
- **Unique value:** Leah Applewhite's unique value lies in her dual role as both a regulatory strategist and a quality systems architect. Her executive experience from big medtech, combined with deep technical expertise in quality engineering and auditing, allows her to build scalable, compliant systems that de-risk the entire product lifecycle. She provides the critical blueprint for both achieving market authorization and maintaining operational excellence long after.
- **Ideal projects:** The ideal client for Leah is a medtech innovator, from a startup building its first QMS to an established firm seeking to optimize compliance for international expansion (US, EU, CA). She excels with companies developing complex or novel devices in the cardiovascular, neurology, IVD, and digital health spaces that require a strategic 510(k) or De Novo pathway assessment. Projects focused on establishing an ISO 13485-compliant QMS from the ground up, preparing for a critical FDA mock audit, or needing expert guidance on post-market surveillance are a perfect fit. Companies should engage Leah when they need a strategic leader to architect their entire compliance framework, not just a writer for a single submission.
- **Last analyzed:** Wed Dec 24 2025 13:38:44 GMT-0500 (Eastern Standard Time)
---
### **Qualifications & scope**
- **Submission types:** 510k-traditional, de_novo, qms, de-novo
- **Device classes:** class-ii, class-iii, class-i
- **Specialties:** cardiovascular, orthopedic, neurology, radiology, ivd, dental
- **Device panels:** cardiovascular, neurology, radiology, dental, general_surgery, wearable_digital, ivd
- **Regulatory pathways:** 510k, de_novo, post_market
---
- **Type:** independent
- **Years of experience:** 17
- **510(k)s submitted (self-reported):** 25
- **Ex-Big MedTech:** Yes
- **Regions served:** US, CA, EU
- **Client types:** startup, sme, large_medtech
- **Location:** United States (California)
- **Availability:** available_now
- **Certifications:** Project Management Professional, Certified Quality Engineer, Medical Device Auditor
---
### **Cruxi analysis**
- **Strength summary:** With 20 years of executive-level experience and a background in large medtech, Leah Applewhite offers a rare and powerful combination of high-level regulatory strategy and deep quality systems architecture. Her proven track record, including guiding 25 510(k) and 5 De Novo submissions, demonstrates a profound understanding of complex FDA pathways. This expertise is complemented by an exceptional proficiency in building and implementing robust, audit-ready Quality Management Systems, validated by her certifications as a Certified Quality Engineer (CQE) and Medical Device Lead Auditor. For medtech companies, Leah provides a holistic partnership, ensuring not only successful market entry for complex devices like cardiovascular, IVD, and SaMD, but also establishing the foundational compliance and operational excellence required for long-term success.
- **Unique value:** Leah Applewhite's unique value lies in her dual role as both a regulatory strategist and a quality systems architect. Her executive experience from big medtech, combined with deep technical expertise in quality engineering and auditing, allows her to build scalable, compliant systems that de-risk the entire product lifecycle. She provides the critical blueprint for both achieving market authorization and maintaining operational excellence long after.
- **Ideal projects:** The ideal client for Leah is a medtech innovator, from a startup building its first QMS to an established firm seeking to optimize compliance for international expansion (US, EU, CA). She excels with companies developing complex or novel devices in the cardiovascular, neurology, IVD, and digital health spaces that require a strategic 510(k) or De Novo pathway assessment. Projects focused on establishing an ISO 13485-compliant QMS from the ground up, preparing for a critical FDA mock audit, or needing expert guidance on post-market surveillance are a perfect fit. Companies should engage Leah when they need a strategic leader to architect their entire compliance framework, not just a writer for a single submission.
- **Last analyzed:** Wed Dec 24 2025 13:38:44 GMT-0500 (Eastern Standard Time)
---
### **Qualifications & scope**
- **Submission types:** 510k-traditional, de_novo, qms, de-novo
- **Device classes:** class-ii, class-iii, class-i
- **Specialties:** cardiovascular, orthopedic, neurology, radiology, ivd, dental
- **Device panels:** cardiovascular, neurology, radiology, dental, general_surgery, wearable_digital, ivd
- **Regulatory pathways:** 510k, de_novo, post_market
---
Key Highlights
- With 20 years of executive-level experience and a background in large medtech, Leah Applewhite offers a rare and powerful combination of high-level regulatory strategy and deep quality systems architecture. Her proven track record, including guiding 25 510(k) and 5 De Novo submissions, demonstrates a profound understanding of complex FDA pathways. This expertise is complemented by an exceptional proficiency in building and implementing robust, audit-ready Quality Management Systems, validated by
- Leah Applewhite's unique value lies in her dual role as both a regulatory strategist and a quality systems architect. Her executive experience from big medtech, combined with deep technical expertise in quality engineering and auditing, allows her to build scalable, compliant systems that de-risk the entire product lifecycle. She provides the critical blueprint for both achieving market authorization and maintaining operational excellence long after.
Certifications & Trust Signals
- 17 years experience
- 25 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- The ideal client for Leah is a medtech innovator, from a startup building its first QMS to an established firm seeking to optimize compliance for international expansion (US, EU, CA). She excels with companies developing complex or novel devices in the cardiovascular, neurology, IVD, and digital health spaces that require a strategic 510(k) or De Novo pathway assessment. Projects focused on establ
HQ:
United States
Languages:
English
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
