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Mark Agostino

Regulatory Affairs Consultant

Mark Agostino is an accomplished regulatory affairs professional with over 25 years of experience in QA and RA leadership and consulting. He specializes in managing FDA and worldwide regulatory submissions for medical devices and combination products. Mark has authored and reviewed over 20 successful 510(k), PMA, and CE marking regulatory submissions. His experience spans both startups and large o...

Experience: 25+ years

Submissions: 10 510(k), 1 De Novo, 1 PMA

Expertise & Specializations

Regulatory Pathways

510kPmaDe Novo

Device Specialties

AnesthesiologyCardiovascularIvd

Regions Served

Mark Agostino provides regulatory consulting services to clients in:

United States (FDA)

Executive Summary

Professional Overview

Mark Agostino is an accomplished regulatory affairs professional with over 25 years of experience in QA and RA leadership and consulting. He specializes in managing FDA and worldwide regulatory submissions for medical devices and combination products. Mark has authored and reviewed over 20 successfu...

Core Specializations

Regulatory Pathways

510kPmaDe Novo

Device Specialties

AnesthesiologyCardiovascularIvd

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
  • Background: 25+ years of regulatory experience.

Cruxi view

Mark Agostino offers a compelling blend of extensive experience and focused expertise in medical device regulatory affairs. With over 25 years in QA/RA leadership and consulting, he brings a proven track record of successfully navigating FDA and international regulatory landscapes. His experience includes authoring and reviewing over 20 successful 510(k), PMA, and CE marking submissions, demonstrating a deep understanding of regulatory requirements. Mark's experience hosting FDA, Notified Body, and worldwide regulatory health authority inspections further strengthens his ability to guide clients through the entire regulatory process, from initial submission to post-market compliance.

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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