WZ

Wayne L. Pines and Jessica L. Zeller

Editors

Food and Drug Law Institute (FDLI) specializes in providing FDA regulatory consulting services to medical device companies, offering expertise in regulatory strategy, compliance, quality systems, risk management, clinical trials, and labeling and advertising.

Experience: 7+ years

Submissions: 12 510(k)

Expertise & Specializations

Regulatory Pathways

510kDe NovoPmaIdePre-Submission

Device Specialties

General HospitalCardiovascularNeurology

Executive Summary

Professional Overview

Food and Drug Law Institute (FDLI) specializes in providing FDA regulatory consulting services to medical device companies, offering expertise in regulatory strategy, compliance, quality systems, risk management, clinical trials, and labeling and advertising.

Core Specializations

Regulatory Pathways

510kDe NovoPmaIdePre-Submission

Device Specialties

General HospitalCardiovascularNeurology

Services Offered

ISO 13485 Consulting
Quality management system development, gap analysis, and ISO 13485 certification support for medical device manufacturers.
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 entry represents a published conference proceeding edited by Wayne L. Pines and Jessica L. Zeller, indicating expertise in FDA regulatory matters. The involvement of 24 contributing authors suggests a broad and deep understanding of the subject matter.

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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