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Leavitt Partners

Regulatory Consulting Firm

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 navigat...

Experience: 15+ years

Submissions: 25 510(k), 5 De Novo, 3 PMA

Expertise & Specializations

Regulatory Pathways

510kDe NovoPmaIdeQ Sub

Device Specialties

IvdCardiovascularNeurologyRadiologyOrthopedic

Regions Served

Leavitt Partners provides regulatory consulting services to clients in:

United States (FDA)European Union (MDR/IVDR)

Credentials & Recognition

Professional Experience

Former FDA Regulatory Specialist
Verified FDA experience

Executive Summary

Professional Overview

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 enterpri...

Core Specializations

Regulatory Pathways

510kDe NovoPmaIdeQ Sub

Device Specialties

IvdCardiovascularNeurologyRadiologyOrthopedic

Services Offered

ISO 13485 Consulting
Quality management system development, gap analysis, and ISO 13485 certification support for medical device manufacturers.
FDA Mock Audit
Pre-inspection preparation, mock FDA audits, and readiness assessments to ensure compliance before official FDA inspections.
ISO 14971 Consulting
Risk management system development, risk analysis, and ISO 14971 compliance support for medical device risk management.
Regulatory Pathway Assessment
Strategic assessment to determine the appropriate FDA regulatory pathway (510(k), De Novo, PMA) for your medical device.
510(k) Authoring & Submission
Complete 510(k) submission preparation, documentation authoring, and FDA submission management.
De Novo & PMA Strategy
Strategic planning and support for De Novo and PMA pathways, including clinical trial design and FDA meeting preparation.
QMS Setup & Implementation
Quality management system design, implementation, and validation to meet FDA and ISO requirements.
Post-Market Support
Post-market surveillance, adverse event reporting, and ongoing regulatory compliance support.

Cruxi Independent Snapshot

Best suited for

  • • MedTech companies seeking expert regulatory guidance

Experience signals

  • Former roles: Former FDA regulatory specialist.
  • Regions: US, EU
  • Background: 15+ years of regulatory experience.

Cruxi view

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.

This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.

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