What services does Michael G. Morello offer?

Michael G. Morello 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 Michael G. Morello support?

Michael G. Morello supports 510(k), PMA, Post-market and related FDA lifecycle activities.

What specialties does Michael G. Morello work in?

Michael G. Morello commonly supports IVD, Ophthalmic device areas.

How much regulatory experience does Michael G. Morello have?

Michael G. Morello has 23+ years in regulatory and quality work.

Michael G. Morello — 510(k) & PMA Consultant (IVD/Ophthalmic)

Q: What regions does Michael G. Morello serve?

Regions served include: United States (FDA), European Union (MDR/IVDR), Canada (Health Canada), Asia-Pacific, Latin America.

FDA Regulatory Compliance Consultant

Highly accomplished FDA Regulatory Compliance Consultant with over 15 years of progressive experience in developing and maintaining robust quality management systems, conducting comprehensive compliance assessments, audits, and gap analyses. Proven expertise in implementation plan development and regulatory intelligence across Pharmaceutical, In-Vitro Diagnostics, Medical Device, and Biotech indus...

Experience: 23+ years

Expertise & Specializations

Regulatory Pathways

510(k)PMAPost-market

Device Specialties

IVDOphthalmic

Regions Served

Michael G. Morello provides regulatory consulting services to clients in:

United States (FDA)European Union (MDR/IVDR)Canada (Health Canada)Asia-PacificLatin America

Credentials & Recognition

Education & Credentials

Holds a Bachelor's Degree in Biology from Lycoming College and has pursued Master's level coursework in Pharmaceutical Quality Assurance/Regulatory Affairs at Temple University, covering critical areas like cGMPs and Food & Drug Law. Further enhanced expertise through HarvardX's 'Improving Global Health: Focusing on Quality and Safety' and The George Washington University's 'National Cybersecurity and Resilience in 2025.' This strong academic foundation provides a comprehensive understanding of scientific principles and regulatory frameworks essential for the medtech industry.

Certifications

National Cybersecurity and Resilience in 2025
The George Washington University-Collge of Professional Studies

Improving Global Health: Focusing on Quality and Safety
Harvard School of Public Health

Professional Experience

Possesses extensive experience as an FDA Regulatory Compliance Consultant, offering strategic guidance for quality management systems, compliance assessment, and regulatory intelligence across pharmaceutical, IVD, medical device, and biotech sectors. Demonstrated success in performing FDA GMP, DEA, and ISO compliance activities, including audits and QMS strategies. Proven ability to represent companies during FDA inspections and draft corrective action responses. Experience includes supplier quality management, international regulatory submissions (CE Marking), and managing global regulatory affairs for diverse product lines. A dedicated professional with a commitment to ensuring robust compliance and driving continuous improvement within organizations.

Former Big MedTech RA Leader
Enterprise experience

Executive Summary

Professional Overview

Core Specializations

Regulatory Pathways

510(k)PMAPost-market

Device Specialties

IVDOphthalmic

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, APAC, LATAM
Background: 23+ years of regulatory experience.

Cruxi view

With a 23-year career foundation and over 15 years in regulatory compliance, Michael G. Morello offers a rare blend of strategic regulatory leadership and deep quality systems expertise. His proficiency across the full device lifecycle, from developing robust QMS (ISO 13485) and conducting mock FDA audits to authoring complex global submissions (510(k), PMA, CE Marking), makes him an invaluable end-to-end partner. Specializing in high-growth areas like In-Vitro Diagnostics (IVD) and Ophthalmic devices, he has a proven track record of navigating all device classes (I, II, and III). This comprehensive skill set, further enhanced by forward-looking expertise in cybersecurity, ensures medtech companies not only achieve market access but also build a sustainable culture of compliance and continuous improvement.

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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