What services does Lexology offer?

Lexology offers Regulatory Pathway Assessment, 510(k) Submission Authoring, De Novo & PMA Strategy, QMS Setup & Implementation and other FDA regulatory consulting services for medical device companies.

What regulatory pathways does Lexology specialize in?

Lexology specializes in 510k, De Novo, Ide and other FDA regulatory pathways for medical devices.

What is Lexology's regulatory experience?

Lexology has 7+ years of experience, 3+ 510(k) submissions in FDA regulatory affairs.

Lexology

Excluding or Limiting FDA Regulatory Expert Opinion

Lexology is a specialized FDA regulatory consultant with 7 years of experience, focusing on providing expert guidance for medical device companies. They excel in navigating complex regulatory pathways, including 510(k) submissions, pre-submission meetings, IDE, and IND applications. Their expertise extends to critical areas such as regulatory submissions, risk management, usability engineering, cl...

Experience: 7+ years

Submissions: 3 510(k)

Expertise & Specializations

Regulatory Pathways

510kDe NovoIdePre-Submission

Device Specialties

General-Hospital

Executive Summary

Professional Overview

Core Specializations

Regulatory Pathways

510kDe NovoIdePre-Submission

Device Specialties

General-Hospital

Services Offered

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

Background: 7+ years of regulatory experience.

Cruxi view

This Lexology page provides legal insights related to FDA regulatory expert opinions. The article likely offers valuable information on the legal aspects of regulatory submissions and expert testimony.

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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