What services does Tammy Lavery offer?

Tammy Lavery 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 Tammy Lavery specialize in?

Tammy Lavery specializes in 510k, De Novo, Pma and other FDA regulatory pathways for medical devices.

What is Tammy Lavery's regulatory experience?

Tammy Lavery has 30+ years of experience in FDA regulatory affairs.

Tammy Lavery

VP, Regulatory Affairs and Quality Assurance

A seasoned Global Quality and Regulatory Compliance Executive with over two decades of leadership in the medical device industry. Tammy Lavery possesses deep expertise in securing FDA approvals, developing and implementing global regulatory strategies, and managing robust Quality Management Systems (ISO 13485, MDSAP). Her experience spans new product development, risk management (ISO 14971), clini...

Experience: 30+ years

Expertise & Specializations

Regulatory Pathways

510kDe NovoPmaIdeQ Sub

Device Specialties

CardiovascularRadiologyGeneral SurgeryDentalAnesthesiology

Regions Served

Tammy Lavery provides regulatory consulting services to clients in:

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

Credentials & Recognition

Certifications

Regulatory Affairs Certification
RAPS

Preparing the CMC Section for NDAs/INDs/CTDs
CfPIE
2020

Clinical Research Assistant 10 Week On-Boarding
Barnett International

Collaborative Institutional Training Initiative (Citi Program)
Citi Program

Professional Experience

Former Big MedTech RA Leader
Enterprise experience

Executive Summary

Professional Overview

Core Specializations

Regulatory Pathways

510kDe NovoPmaIdeQ Sub

Device Specialties

CardiovascularRadiologyGeneral SurgeryDentalAnesthesiology

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

Regions: US, EU, CA
Background: 30+ years of regulatory experience.

Cruxi view

Tammy Lavery offers medtech companies a powerful combination of executive-level strategic vision and hands-on regulatory execution, backed by 30 years of industry leadership. Her deep expertise spans the most challenging regulatory pathways, including 510(k), De Novo, and PMA submissions, for a wide range of complex devices such as cardiovascular, SaMD, and implantables (Class I-III). What truly distinguishes Tammy is her versatile experience, having served as a VP of RA/QA and a direct consultant, enabling her to effectively guide both startups and large corporations through the entire product lifecycle. She is a proven leader in developing global regulatory strategies for US, EU, and Canadian markets, managing robust ISO 13485/MDSAP compliant QMS, and securing critical market approvals, making her an invaluable asset for achieving commercial success.

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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