Medical Device Regulatory Affairs Consulting

Regulatory Affairs Support for Medical Device Companies

EZ Regulatory helps MedTech companies move critical regulatory work forward across FDA strategy, global registrations, lifecycle changes, remediation programs, and regulatory operations.

Support can be provided as a strategic advisor, submission lead, project owner, or interim regulatory leader, helping teams navigate complex requirements while maintaining momentum across key business objectives.

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Regulatory Consulting

Flexible Regulatory Affairs leadership across the entire device lifecycle

EZ Regulatory was built to provide experienced regulatory leadership without the overhead of a full-time hire. With experience spanning startups, growth-stage companies, global manufacturers, and some of the world’s largest MedTech organizations, support is tailored to the stage, complexity, and objectives of each program.

Whether the need is strategic guidance, execution support, regulatory remediation, or interim leadership, the focus remains the same: helping teams make confident decisions, reduce regulatory risk, and keep products moving forward.

Consulting Service Offerings

RA Leadership

Dedicated Regulatory Affairs support when you need experienced decision-making without adding a full-time headcount.

Regulatory Managerial Support
Regulatory Team Support
Regulatory roadmaps
Executive guidance
Cross-functional leadership

FDA Strategies & Submissions

Submission strategy and execution support for companies preparing, revising, or defending FDA pathways.

510(k) (Traditional, Special, Abbreviated)
De Novo
PMA & Supplements
IDE
Pre-Submission Meeting Support
Critical FDA Meeting Support

Global Registration Strategy

Turn international growth goals into practical regulatory sequencing and execution plans.

EU MDR
UKCA
Health Canada
Latin America
Australia
Asia & Pacific
Registration Sequencing
Affiliate Support

Lifecycle Changes & Regulatory Impact Assessments

Regulatory support for the operational changes that keep products moving and portfolios compliant.

Site Transfers
Manufacturing Transfers
Sterilization Changes
Material Changes
Packaging Changes
Labeling Changes
FDA Letters to File

Remediation & Regulatory Operations

Leadership for high-volume, complex, and operational regulatory work.

Portfolio Remediation
Documentation Gaps
Regulatory Cleanup Programs
Submission Planning
Process Improvement
Cross-Functional Collaboration

AI & Regulatory Innovation

Support for companies looking to modernize regulatory workflows and reduce manual overhead.

Regulatory Process Optimization
Workflow Automation
AI Strategies
Regulatory Data Modernization
Submission Efficiency

Device Experience

Experience supporting Class I, II, and III medical devices across FDA-recognized product areas, including orthopedic implants, cardiovascular technologies, acute care systems, diagnostic platforms, software-enabled devices, and global lifecycle programs.

Cardiovascular & Vascular Devices

Drug-Eluting Stents
Coronary & Peripheral Vascular Devices
Structural Heart & Transcatheter Valve Technologies
Implantable Cardiovascular Devices
Drug-Device Combination Products

Orthopedic Implants & Joint Reconstruction

Hip Replacement Implant Systems
Acetabular Cups, Liners & Femoral Components
Knee Replacement Implant Systems
Patellofemoral & Tibiofemoral Components
Orthopedic Implant Lifecycle Support

Infusion, Vascular Access & Acute Care

Infusion Pumps & Administration Sets
Vascular Access Devices
Acute Care Monitoring Systems
Hospital-Based Device Platforms
Combination Product Support

Neurodiagnostics & Functional Brain Mapping

EEG & Neurodiagnostic Systems
Functional Brain Mapping Technologies
Neuromonitoring Platforms
Diagnostic Device Submissions
Clinical Workflow Integration

Patient Monitoring & Diagnostic Technologies

Patient Monitoring Devices
Diagnostic Platforms
Clinical Measurement Systems
Connected Monitoring Technologies
Risk-Based Regulatory Strategy

Software & Digital Health

Software as a Medical Device (SaMD)
Connected Medical Device Platforms
Clinical Decision Support Software
Device Software Lifecycle Management
Digital Health Regulatory Strategy

About Charles

I'm Charles Neitzel, a Medical Device Regulatory Affairs professional with more than 17 years of experience helping companies navigate complex regulatory challenges across the product lifecycle. My background spans startups, global manufacturers, and consulting organizations supporting FDA submissions, international registrations, remediation programs, lifecycle management, and regulatory operations.

Throughout my career, I've supported organizations including Abbott, Pfizer/ICU Medical, RQM+, KPMG, Zimmer Biomet, Stryker, and numerous startup and emerging MedTech companies. I've worked across both strategic and operational Regulatory Affairs initiatives, from new product development and FDA submissions to global registrations, manufacturing transfers, remediation efforts, and portfolio-wide regulatory programs.

The work I enjoy most sits at the intersection of regulatory strategy, business goals, and execution. Whether developing a global registration roadmap, solving a complex product change challenge, supporting an FDA pathway for an innovative technology, or improving regulatory operations through automation, I enjoy helping companies turn uncertainty into clear, executable plans.

Clients engage EZ Regulatory when they need experienced Regulatory Affairs leadership without the cost and commitment of a full-time hire.

17+ YearsMedical Device Regulatory Affairs experience across industry and consulting.

Global Market AccessFDA, EU MDR, UKCA, Health Canada, LATAM, APAC, and international registration strategy.

Strategic & Operational RASubmissions, lifecycle changes, remediation, regulatory operations, and portfolio leadership.

Work with Charles

CONSULTING FAQ

Frequently Asked Questions

Learn more about the types of projects, companies, and Regulatory Affairs support provided through EZ Regulatory Consulting.

What types of regulatory projects do you typically support?

Projects range from FDA submissions and global registrations to lifecycle changes, remediation programs, product transfers, regulatory impact assessments, and broader Regulatory Affairs strategy. Many clients engage EZ Regulatory when they have a complex regulatory challenge, limited internal bandwidth, or need experienced leadership to move a program forward.

Do you only support FDA submissions?

No. FDA submissions are only one part of what I do. A significant portion of my experience involves global registration strategy, lifecycle management, manufacturing and supplier changes, remediation efforts, regulatory operations, and helping companies navigate complex regulatory decisions across multiple markets.

Can you act as one of our Regulatory Team Members?

Yes. Many engagements involve functioning as an extension of the internal Regulatory Affairs team. Depending on the need, support may include regulatory strategy, project leadership, submission planning, cross-functional coordination, executive communication, and day-to-day regulatory decision making.

What types of companies are the best fit?

I work with startups, emerging growth companies, and established medical device manufacturers. Some clients need help developing their first regulatory strategy, while others need support managing large product portfolios, international registrations, remediation programs, or organizational initiatives.

Do you work independently or alongside internal teams?

Both. Some engagements are fully independent consulting projects. Others involve working closely with Regulatory Affairs, Quality, Clinical, R&D, Operations, Marketing, and executive leadership teams to support broader business objectives.

What is your regulatory background?

I have more than 17 years of experience in Medical Device Regulatory Affairs across industry and consulting environments including Abbott, Pfizer/ICU Medical, RQM+, KPMG, Zimmer Biomet, Stryker, and startup/emerging MedTech companies. My experience includes FDA submissions, PMA programs, EU MDR, Health Canada, LATAM, APAC, lifecycle management, remediation programs, regulatory operations, and global market access strategy.

What areas of Regulatory Affairs do you enjoy most?

Three areas stand out: building global registration and market expansion strategies; solving complex lifecycle and operational regulatory challenges such as site transfers, manufacturing changes, sterilization changes, remediation programs, and portfolio-wide initiatives; and helping innovative companies develop practical FDA pathways while exploring how AI and automation can improve Regulatory Affairs processes.

EXPANDING THE ECOSYSTEM

Helping MedTech Companies Beyond Regulatory Strategy

EZ Distribute

Helping MedTech companies navigate what comes after FDA regulatory approvals through international expansion planning, commercialization strategy, and trusted partner connections.

Learn About EZ Distribute

EZ 510k

Automated submission software designed to reduce 510(k) friction, improve organization, and support more efficient FDA submission preparation.

Learn About EZ 510k

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Let's Discuss Your Regulatory Goals

Whether you're developing a regulatory strategy, preparing a submission, managing product changes, pursuing international registrations, improving regulatory processes, or looking for experienced Regulatory Affairs leadership, let's start with a conversation.

support@ezregulatory.com Book Strategy Call