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.
About
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.
Additional information
### **Additional information**
- **Type:** independent
- **Years of experience:** 25
- **510(k)s submitted (self-reported):** 10
- **Regions served:** US
- **Client types:** startup, sme, large_medtech
- **Location:** United States (Massachusetts)
- **Availability:** available_now
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### **Cruxi analysis**
- **Strength summary:** 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.
- **Unique value:** Mark's unique value lies in his combination of extensive hands-on experience with both 510(k) and PMA submissions, coupled with his direct experience hosting regulatory inspections, providing clients with a comprehensive understanding of the regulatory lifecycle from submission to compliance.
- **Ideal projects:** The ideal project for Mark involves Class II or Class III medical devices requiring 510(k), PMA, or international submissions, particularly in the fields of anesthesiology, cardiovascular devices, or IVDs. He is well-suited for companies, both startups and larger organizations, seeking guidance on QMS implementation and maintenance, clinical trial design, and navigating complex regulatory pathways. Projects involving software as a medical device (SaMD) would also be a strong fit, given his listed specialty. Companies needing assistance with preparing for and hosting regulatory inspections would also benefit greatly from his experience.
- **Last analyzed:** Sun Dec 14 2025 01:12:15 GMT-0500 (Eastern Standard Time)
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### **Qualifications & scope**
- **Submission types:** 510k-traditional, pma, clinical-trials, international, qms, de-novo
- **Device classes:** class-ii, class-iii
- **Specialties:** anesthesiology, cardiovascular, ivd, software-samd, other, quality management systems, clinical trials
- **Device panels:** anesthesiology, cardiovascular, ivd
- **Regulatory pathways:** 510k, pma, de_novo
---
- **Type:** independent
- **Years of experience:** 25
- **510(k)s submitted (self-reported):** 10
- **Regions served:** US
- **Client types:** startup, sme, large_medtech
- **Location:** United States (Massachusetts)
- **Availability:** available_now
---
### **Cruxi analysis**
- **Strength summary:** 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.
- **Unique value:** Mark's unique value lies in his combination of extensive hands-on experience with both 510(k) and PMA submissions, coupled with his direct experience hosting regulatory inspections, providing clients with a comprehensive understanding of the regulatory lifecycle from submission to compliance.
- **Ideal projects:** The ideal project for Mark involves Class II or Class III medical devices requiring 510(k), PMA, or international submissions, particularly in the fields of anesthesiology, cardiovascular devices, or IVDs. He is well-suited for companies, both startups and larger organizations, seeking guidance on QMS implementation and maintenance, clinical trial design, and navigating complex regulatory pathways. Projects involving software as a medical device (SaMD) would also be a strong fit, given his listed specialty. Companies needing assistance with preparing for and hosting regulatory inspections would also benefit greatly from his experience.
- **Last analyzed:** Sun Dec 14 2025 01:12:15 GMT-0500 (Eastern Standard Time)
---
### **Qualifications & scope**
- **Submission types:** 510k-traditional, pma, clinical-trials, international, qms, de-novo
- **Device classes:** class-ii, class-iii
- **Specialties:** anesthesiology, cardiovascular, ivd, software-samd, other, quality management systems, clinical trials
- **Device panels:** anesthesiology, cardiovascular, ivd
- **Regulatory pathways:** 510k, pma, de_novo
---
Key Highlights
- 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,
- Mark's unique value lies in his combination of extensive hands-on experience with both 510(k) and PMA submissions, coupled with his direct experience hosting regulatory inspections, providing clients with a comprehensive understanding of the regulatory lifecycle from submission to compliance.
Certifications & Trust Signals
- 25 years experience
- 10 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- The ideal project for Mark involves Class II or Class III medical devices requiring 510(k), PMA, or international submissions, particularly in the fields of anesthesiology, cardiovascular devices, or IVDs. He is well-suited for companies, both startups and larger organizations, seeking guidance on QMS implementation and maintenance, clinical trial design, and navigating complex regulatory pathways
HQ:
United States
Languages:
English
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
