Mark Agostino
25+ Years QA/RA Leadership: FDA & Intl. Submissions, Inspections, Medical Devices & Comb. Products
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 organizations, and he has successfully hosted FDA, Notified Body, and worldwide regulatory health authority inspections. Mark is adept at navigating complex regulatory pathways and ensuring compliance.
HQ:
United States
Languages:
English
Claim status:
Claimed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 510(k) Strategy & Authoring, 510(k) RTA Remediation / Refuse-to-Accept Fix, Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C)
Pathways Supported:
Traditional 510(k), De Novo, PMA
Device Types Supported:
IVD, SaMD, Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
25
Num510k Submitted:
10
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
anesthesiology, cardiovascular, ivd
Engagement Models:
hourly
Accepting New Clients:
Yes
