What services does DIONE FULLER offer?

DIONE FULLER offers Regulatory Pathway Assessment, Classification Assessment, Predicate Analysis, Test Strategy, 510(k) Authoring & Submission, De Novo & PMA Strategy and other regulatory consulting support depending on project needs.

What pathways does DIONE FULLER support?

DIONE FULLER supports 510(k), IDE, Post-market, De Novo, PMA and related FDA lifecycle activities.

What regions does DIONE FULLER serve?

Regions served include: United States (FDA), European Union (MDR/IVDR), Canada (Health Canada).

How much regulatory experience does DIONE FULLER have?

DIONE FULLER has 14+ years in regulatory and quality work.

DIONE FULLER — 510(k) & IDE Consultant (Cardiovascular/Dental)

Q: What specialties does DIONE FULLER work in?

DIONE FULLER commonly supports Cardiovascular, Dental, Ophthalmic, General Surgery, General-hospital device areas.

Regulatory & Quality Affairs Professional

Accomplished and highly skilled Regulatory & Quality Affairs Professional with 14 years of experience navigating complex global regulatory landscapes for medical devices. Proven expertise in developing and executing comprehensive regulatory strategies, ensuring seamless market access across the US, EU, and Canada. Adept at managing EU MDR, FDA 510(k), and Health Canada submissions, demonstrating a...

Experience: 14+ years

Submissions: 30 510(k), 5 De Novo, 3 PMA

Expertise & Specializations

Regulatory Pathways

510(k)IDEPost-marketDe NovoPMA

Device Specialties

CardiovascularDentalOphthalmicGeneral SurgeryGeneral-hospital

Regions Served

DIONE FULLER provides regulatory consulting services to clients in:

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

Credentials & Recognition

Professional Experience

Accomplished Regulatory & Quality Affairs Professional with over a decade of experience driving global market access for medical devices. Proven expertise in leading complex regulatory strategies and submissions across the US, EU, and Canada, including extensive work with EU MDR, FDA 510(k), and Health Canada regulations. Demonstrated success in navigating challenging regulatory environments and collaborating with cross-functional teams at prominent organizations like Baxter International, Johnson & Johnson, and Medtronic. Adept at managing technical documentation, quality systems, and product lifecycle support, consistently ensuring compliance and facilitating product approvals.

Former Big MedTech RA Leader
Enterprise experience

Executive Summary

Professional Overview

Core Specializations

Regulatory Pathways

510(k)IDEPost-marketDe NovoPMA

Device Specialties

CardiovascularDentalOphthalmicGeneral SurgeryGeneral-hospital

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: 14+ years of regulatory experience.

Cruxi view

With 14 years of experience background, this consultant specializes in medtech regulatory affairs and quality systems, boasting a robust track record of navigating complex global regulatory landscapes for medical devices. Their expertise spans FDA 510(k) and EU MDR submissions, with a proven ability to develop and execute comprehensive regulatory strategies for seamless market access across diverse regions, including the US, EU, and Canada. They possess deep understanding of quality systems (ISO 13485, 21 CFR 820, MDSAP) and technical documentation requirements, making them an exceptional asset for medtech companies seeking regulatory compliance and market access. Their exceptional project management, cross-functional leadership, and proactive approach to risk assessment and deficiency management further solidify their value. This consultant's strong expertise in EU MDR, FDA 510(k), and Health Canada regulations makes them an ideal partner for medtech companies aiming to expand their global presence.

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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