Michael G. Morello — 510(k) & PMA Consultant (IVD/Ophthalmic)
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
Device Specialties
Regions Served
Michael G. Morello provides regulatory consulting services to clients in:
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
The George Washington University-Collge of Professional Studies
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.
Enterprise experience
Executive Summary
Professional Overview
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 re...
Core Specializations
Regulatory Pathways
Device Specialties
Services Offered
Quality management system development, gap analysis, and ISO 13485 certification support for medical device manufacturers.
Pre-inspection preparation, mock FDA audits, and readiness assessments to ensure compliance before official FDA inspections.
Risk management system development, risk analysis, and ISO 14971 compliance support for medical device risk management.
Strategic assessment to determine the appropriate FDA regulatory pathway (510(k), De Novo, PMA) for your medical device.
Complete 510(k) submission preparation, documentation authoring, and FDA submission management.
Strategic planning and support for De Novo and PMA pathways, including clinical trial design and FDA meeting preparation.
Quality management system design, implementation, and validation to meet FDA and ISO requirements.
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 over 15 years of progressive experience, Michael G. Morello offers a rare combination of deep tactical expertise in Quality Management Systems and high-level global regulatory strategy. He provides exceptional value for medtech companies, particularly in the IVD, hematology, and pathology sectors, by adeptly managing the entire product lifecycle from initial compliance assessments to successful 510(k) and PMA submissions. What truly sets him apart is his forward-thinking specialization in cybersecurity, backed by a certification from George Washington University, which addresses a critical and evolving regulatory need. This unique blend of foundational quality system mastery, a proven track record in global submissions, and modern cybersecurity intelligence makes him an invaluable strategic partner for companies seeking robust and resilient market access.
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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