Michael G. Morello
Expert FDA Regulatory Compliance Consultant | QMS, Audits, 510k, PMA, Global Submissions | 15+ Yrs Exp.
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 industries. Adept at managing FDA GMP, DEA & ISO compliance, cybersecurity, and regulatory strategy for clients. Successfully navigated complex regulatory pathways, including 510(k)s, CE Marking, and PMA submissions, with a strong track record of positive client outcomes and successful product registrations globally. Dedicated to ensuring client adherence to stringent regulatory standards and driving continuous improvement.
About
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 industries. Adept at managing FDA GMP, DEA & ISO compliance, cybersecurity, and regulatory strategy for clients. Successfully navigated complex regulatory pathways, including 510(k)s, CE Marking, and PMA submissions, with a strong track record of positive client outcomes and successful product registrations globally. Dedicated to ensuring client adherence to stringent regulatory standards and driving continuous improvement.
Additional information
### **Additional information**
- **Type:** independent
- **Years of experience:** 23
- **Ex-Big MedTech:** Yes
- **Regions served:** US, EU, CA, APAC, LATAM
- **Client types:** sme, large_medtech, startup
- **Location:** United States (Pennsylvania)
- **Availability:** available_now
- **Certifications:** National Cybersecurity and Resilience in 2025, Improving Global Health: Focusing on Quality and Safety
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### **Cruxi analysis**
- **Strength summary:** 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.
- **Unique value:** Michael's unique value lies in his holistic approach, seamlessly integrating foundational quality system architecture with sophisticated global regulatory submission strategy. Unlike narrowly focused specialists, he ensures that a company's path to market is built on a robust and scalable compliance framework, mitigating risks from development through post-market surveillance. This powerful combination of QMS mastery and successful submission execution across diverse device types makes him a strategic asset for achieving both immediate clearance and long-term commercial success.
- **Ideal projects:** The ideal client for Michael is a startup or SME medtech company developing a novel Class II or III device, particularly within the IVD space, that requires both strategic guidance and hands-on execution. He is perfectly suited for projects involving the establishment of a compliant QMS from the ground up while simultaneously developing a multi-market regulatory strategy for the US and EU. Companies facing their first complex 510(k) or PMA submission, preparing for an FDA inspection, or seeking to expand their global regulatory footprint would find his expertise particularly impactful. His ability to serve clients of all sizes means he can scale his support, acting as a fractional regulatory department for emerging companies or a specialized expert for large medtech.
- **Last analyzed:** Wed Jan 28 2026 17:41:37 GMT-0500 (Eastern Standard Time)
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### **Qualifications & scope**
- **Submission types:** 510k-traditional, qms, international
- **Device classes:** class-i, class-ii, class-iii
- **Specialties:** ivd
- **Device panels:** ivd, ophthalmic
- **Regulatory pathways:** 510k, pma, post_market
---
- **Type:** independent
- **Years of experience:** 23
- **Ex-Big MedTech:** Yes
- **Regions served:** US, EU, CA, APAC, LATAM
- **Client types:** sme, large_medtech, startup
- **Location:** United States (Pennsylvania)
- **Availability:** available_now
- **Certifications:** National Cybersecurity and Resilience in 2025, Improving Global Health: Focusing on Quality and Safety
---
### **Cruxi analysis**
- **Strength summary:** 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.
- **Unique value:** Michael's unique value lies in his holistic approach, seamlessly integrating foundational quality system architecture with sophisticated global regulatory submission strategy. Unlike narrowly focused specialists, he ensures that a company's path to market is built on a robust and scalable compliance framework, mitigating risks from development through post-market surveillance. This powerful combination of QMS mastery and successful submission execution across diverse device types makes him a strategic asset for achieving both immediate clearance and long-term commercial success.
- **Ideal projects:** The ideal client for Michael is a startup or SME medtech company developing a novel Class II or III device, particularly within the IVD space, that requires both strategic guidance and hands-on execution. He is perfectly suited for projects involving the establishment of a compliant QMS from the ground up while simultaneously developing a multi-market regulatory strategy for the US and EU. Companies facing their first complex 510(k) or PMA submission, preparing for an FDA inspection, or seeking to expand their global regulatory footprint would find his expertise particularly impactful. His ability to serve clients of all sizes means he can scale his support, acting as a fractional regulatory department for emerging companies or a specialized expert for large medtech.
- **Last analyzed:** Wed Jan 28 2026 17:41:37 GMT-0500 (Eastern Standard Time)
---
### **Qualifications & scope**
- **Submission types:** 510k-traditional, qms, international
- **Device classes:** class-i, class-ii, class-iii
- **Specialties:** ivd
- **Device panels:** ivd, ophthalmic
- **Regulatory pathways:** 510k, pma, post_market
---
Key Highlights
- 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 d
- Michael's unique value lies in his holistic approach, seamlessly integrating foundational quality system architecture with sophisticated global regulatory submission strategy. Unlike narrowly focused specialists, he ensures that a company's path to market is built on a robust and scalable compliance framework, mitigating risks from development through post-market surveillance. This powerful combination of QMS mastery and successful submission execution across diverse device types makes him a str
Certifications & Trust Signals
- 23 years experience
Buyer Snapshot
Best for
- The ideal client for Michael is a startup or SME medtech company developing a novel Class II or III device, particularly within the IVD space, that requires both strategic guidance and hands-on execution. He is perfectly suited for projects involving the establishment of a compliant QMS from the ground up while simultaneously developing a multi-market regulatory strategy for the US and EU. Compani
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), PMA
Device Types Supported:
IVD, Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
23
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
Yes
Device Panels:
ivd, ophthalmic
Engagement Models:
hourly
Accepting New Clients:
No
