Leavitt Partners
Leavitt Partners: Expert FDA Regulatory Consulting for MedTech Innovation
Leavitt Partners is a distinguished FDA regulatory consulting firm with over 15 years of experience, renowned for its deep bench of former FDA regulatory specialists and seasoned industry veterans. They empower medical device companies of all sizes, from innovative startups to large medtech enterprises, to accelerate product development and achieve seamless market entry. The firm excels in navigating the complexities of FDA submissions, offering expert guidance on regulatory strategies, pathway assessments, and robust compliance solutions across all device classes. Leavitt Partners is committed to fostering efficient regulatory pathways and ensuring clients' life-changing technologies reach patients swiftly and safely, transforming innovation into market success.
About
Leavitt Partners is a distinguished FDA regulatory consulting firm with over 15 years of experience, renowned for its deep bench of former FDA regulatory specialists and seasoned industry veterans. They empower medical device companies of all sizes, from innovative startups to large medtech enterprises, to accelerate product development and achieve seamless market entry. The firm excels in navigating the complexities of FDA submissions, offering expert guidance on regulatory strategies, pathway assessments, and robust compliance solutions across all device classes. Leavitt Partners is committed to fostering efficient regulatory pathways and ensuring clients' life-changing technologies reach patients swiftly and safely, transforming innovation into market success.
Additional information
### **Additional information**
- **Type:** firm
- **Company:** Leavitt Partners
- **Years of experience:** 15
- **510(k)s submitted (self-reported):** 25
- **Ex-FDA:** Yes
- **Regions served:** US, EU
- **Client types:** startup, sme, large_medtech
- **Location:** US (Washington)
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** With over 15 years of experience and a distinguished bench of former FDA regulatory specialists and seasoned industry veterans, Leavitt Partners offers unparalleled FDA regulatory consulting expertise for medtech companies. Their team's deep understanding of FDA submissions, regulatory strategies, and compliance solutions across all device classes (I, II, III) is a significant asset. They possess proven proficiency in navigating complex pathways like 510(k) (traditional and special), De Novo, and PMA, demonstrated by their submitted numbers. Leavitt Partners excels in specialized areas including IVD, SaMD, AI/ML, and cardiovascular devices, making them an indispensable partner for companies seeking to accelerate innovation and achieve seamless, compliant market entry.
- **Unique value:** Leavitt Partners' unique value proposition lies in its formidable combination of extensive hands-on experience from former FDA regulatory leaders and a comprehensive service offering covering the entire medical device lifecycle. Their specialized expertise, particularly in IVDs and emerging technologies like AI/ML and SaMD, coupled with broad knowledge across all device classes and submission types, provides medtech companies with a distinct advantage in achieving efficient regulatory compliance and market access.
- **Ideal projects:** The ideal medtech client for Leavitt Partners is a company, regardless of size (startup, SME, or large medtech), developing innovative devices that require expert navigation through intricate FDA regulatory pathways such as 510(k), De Novo, or PMA. This firm is particularly well-suited for projects involving advanced technologies including Software as a Medical Device (SaMD), AI/ML, wearable devices, implantables, and combination products, especially within the IVD, Neurology, and Cardiovascular panels. Companies embarking on their first FDA submission, facing challenging regulatory hurdles, or seeking to establish and maintain robust Quality Management Systems (ISO 13485, ISO 14971) will find Leavitt Partners to be an exceptional strategic partner. Engaging them early in the development lifecycle or for post-market support are key opportunities to leverage their comprehensive expertise.
- **Confidence score:** 90/100
- **Last analyzed:** Sat Dec 20 2025 01:42:08 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, de-novo, pma, clinical-trials, qms, international
- **Device classes:** class-i, class-ii, class-iii
- **Specialties:** ivd, software-samd, cardiovascular, neurology, radiology, orthopedic, regulatory strategy, risk management, quality system implementation, quality management systems
- **Device panels:** ivd, cardiovascular, neurology, radiology, orthopedic, wearable_digital
- **Regulatory pathways:** 510k, de_novo, pma, ide, q_sub, hde, post_market
- **Type:** firm
- **Company:** Leavitt Partners
- **Years of experience:** 15
- **510(k)s submitted (self-reported):** 25
- **Ex-FDA:** Yes
- **Regions served:** US, EU
- **Client types:** startup, sme, large_medtech
- **Location:** US (Washington)
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** With over 15 years of experience and a distinguished bench of former FDA regulatory specialists and seasoned industry veterans, Leavitt Partners offers unparalleled FDA regulatory consulting expertise for medtech companies. Their team's deep understanding of FDA submissions, regulatory strategies, and compliance solutions across all device classes (I, II, III) is a significant asset. They possess proven proficiency in navigating complex pathways like 510(k) (traditional and special), De Novo, and PMA, demonstrated by their submitted numbers. Leavitt Partners excels in specialized areas including IVD, SaMD, AI/ML, and cardiovascular devices, making them an indispensable partner for companies seeking to accelerate innovation and achieve seamless, compliant market entry.
- **Unique value:** Leavitt Partners' unique value proposition lies in its formidable combination of extensive hands-on experience from former FDA regulatory leaders and a comprehensive service offering covering the entire medical device lifecycle. Their specialized expertise, particularly in IVDs and emerging technologies like AI/ML and SaMD, coupled with broad knowledge across all device classes and submission types, provides medtech companies with a distinct advantage in achieving efficient regulatory compliance and market access.
- **Ideal projects:** The ideal medtech client for Leavitt Partners is a company, regardless of size (startup, SME, or large medtech), developing innovative devices that require expert navigation through intricate FDA regulatory pathways such as 510(k), De Novo, or PMA. This firm is particularly well-suited for projects involving advanced technologies including Software as a Medical Device (SaMD), AI/ML, wearable devices, implantables, and combination products, especially within the IVD, Neurology, and Cardiovascular panels. Companies embarking on their first FDA submission, facing challenging regulatory hurdles, or seeking to establish and maintain robust Quality Management Systems (ISO 13485, ISO 14971) will find Leavitt Partners to be an exceptional strategic partner. Engaging them early in the development lifecycle or for post-market support are key opportunities to leverage their comprehensive expertise.
- **Confidence score:** 90/100
- **Last analyzed:** Sat Dec 20 2025 01:42:08 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, de-novo, pma, clinical-trials, qms, international
- **Device classes:** class-i, class-ii, class-iii
- **Specialties:** ivd, software-samd, cardiovascular, neurology, radiology, orthopedic, regulatory strategy, risk management, quality system implementation, quality management systems
- **Device panels:** ivd, cardiovascular, neurology, radiology, orthopedic, wearable_digital
- **Regulatory pathways:** 510k, de_novo, pma, ide, q_sub, hde, post_market
Key Highlights
- With over 15 years of experience and a distinguished bench of former FDA regulatory specialists and seasoned industry veterans, Leavitt Partners offers unparalleled FDA regulatory consulting expertise for medtech companies. Their team's deep understanding of FDA submissions, regulatory strategies, and compliance solutions across all device classes (I, II, III) is a significant asset. They possess proven proficiency in navigating complex pathways like 510(k) (traditional and special), De Novo, an
- Leavitt Partners' unique value proposition lies in its formidable combination of extensive hands-on experience from former FDA regulatory leaders and a comprehensive service offering covering the entire medical device lifecycle. Their specialized expertise, particularly in IVDs and emerging technologies like AI/ML and SaMD, coupled with broad knowledge across all device classes and submission types, provides medtech companies with a distinct advantage in achieving efficient regulatory compliance
Certifications & Trust Signals
- 15 years experience
- 25 510(k)s submitted (self-reported)
- Ex-FDA
Buyer Snapshot
Best for
- The ideal medtech client for Leavitt Partners is a company, regardless of size (startup, SME, or large medtech), developing innovative devices that require expert navigation through intricate FDA regulatory pathways such as 510(k), De Novo, or PMA. This firm is particularly well-suited for projects involving advanced technologies including Software as a Medical Device (SaMD), AI/ML, wearable devic
HQ:
US
Languages:
English
Status:
listed
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), Special 510(k), De Novo, PMA, Pre-Sub / Q-Sub
Device Types Supported:
IVD, SaMD, Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
15
Num510k Submitted:
25
Ex FDA:
Yes
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
ivd, cardiovascular, neurology, radiology, orthopedic, wearable_digital
Technology Types:
samd, ai_ml, mobile_app, cloud_platform, wearable_patch, implantable, ivd_test, combo_product
Accepting New Clients:
Yes
