DEBORAH MORLEY
Medical Device Regulatory & Clinical Affairs Expert | 30+ Yrs Exp | FDA Submissions | Global Approvals | QMS
Dr. Deborah Morley is a distinguished Regulatory and Clinical Affairs expert with over 30 years of experience in the medical technology industry. She guides startups and established companies through complex regulatory pathways, specializing in strategic planning, PMA, 510(k), and Q-Submission preparation, and clinical trial management. Dr. Morley adeptly navigates global regulatory requirements, fostering strong relationships with agencies like the FDA. Her expertise in Quality Management Systems and scientific acumen make her an invaluable partner for successful medical device commercialization.
About
Dr. Deborah Morley is a distinguished Regulatory and Clinical Affairs expert with over 30 years of experience in the medical technology industry. She guides startups and established companies through complex regulatory pathways, specializing in strategic planning, PMA, 510(k), and Q-Submission preparation, and clinical trial management. Dr. Morley adeptly navigates global regulatory requirements, fostering strong relationships with agencies like the FDA. Her expertise in Quality Management Systems and scientific acumen make her an invaluable partner for successful medical device commercialization.
Additional information
### **Additional information**
- **Type:** independent
- **Years of experience:** 30
- **510(k)s submitted (self-reported):** 3
- **Regions served:** US, EU, CA, APAC, LATAM, MEA
- **Client types:** sme, startup, academic
- **Location:** United States (NJ)
- **Availability:** available_now
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### **Cruxi analysis**
- **Strength summary:** Dr. Deborah Morley offers a rare and powerful combination of deep scientific expertise and seasoned regulatory leadership, refined over 30 years in the medical technology industry. Her Ph.D. in Cardiovascular Physiology provides a profound understanding of complex device mechanisms, which she masterfully applies to regulatory strategy, particularly for high-risk Class III cardiovascular and IVD products. With an exceptional track record that includes successfully guiding 10 PMA submissions and securing multiple Breakthrough Device Designations, she excels at navigating the most demanding FDA pathways. For medtech companies, this translates into a strategic partner who can de-risk development, manage clinical trials, and lead global commercialization efforts with unparalleled scientific and regulatory authority.
- **Unique value:** Dr. Morley's key differentiator is the potent fusion of a scientist's deep technical acumen with a regulatory strategist's proven execution. Her Ph.D. in Cardiovascular Physiology allows her to champion complex, novel technologies with exceptional scientific credibility before regulatory agencies like the FDA. This unique combination makes her an incredibly effective partner for companies commercializing innovative devices that face the highest regulatory hurdles.
- **Ideal projects:** The ideal client for Dr. Morley is a startup or small-to-medium-sized enterprise developing a novel, high-risk medical device, especially a Class III implantable cardiovascular product or a complex IVD. Companies seeking a strategic partner for their entire regulatory journey—from initial pathway assessment and Q-Submission strategy to clinical trial management and PMA authoring—will find her expertise invaluable. She is perfectly suited for projects requiring a Breakthrough Device Designation or navigating a challenging De Novo or PMA pathway for the first time. Engaging Dr. Morley early in the development process is optimal for companies needing to build a robust regulatory and clinical strategy from the ground up for U.S. and global market success.
- **Last analyzed:** Thu Jan 01 2026 21:36:21 GMT-0500 (Eastern Standard Time)
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### **Qualifications & scope**
- **Submission types:** 510k-traditional, pma, clinical-trials, qms, international
- **Device classes:** class-iii, class-ii
- **Specialties:** cardiovascular, hematology, pathology, clinical trials, quality system implementation, quality management systems, risk management, regulatory strategy, other
- **Device panels:** cardiovascular, ivd
- **Regulatory pathways:** 510k, pma, ide, q_sub, hde, post_market, breakthrough_devices, de_novo
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- **Type:** independent
- **Years of experience:** 30
- **510(k)s submitted (self-reported):** 3
- **Regions served:** US, EU, CA, APAC, LATAM, MEA
- **Client types:** sme, startup, academic
- **Location:** United States (NJ)
- **Availability:** available_now
---
### **Cruxi analysis**
- **Strength summary:** Dr. Deborah Morley offers a rare and powerful combination of deep scientific expertise and seasoned regulatory leadership, refined over 30 years in the medical technology industry. Her Ph.D. in Cardiovascular Physiology provides a profound understanding of complex device mechanisms, which she masterfully applies to regulatory strategy, particularly for high-risk Class III cardiovascular and IVD products. With an exceptional track record that includes successfully guiding 10 PMA submissions and securing multiple Breakthrough Device Designations, she excels at navigating the most demanding FDA pathways. For medtech companies, this translates into a strategic partner who can de-risk development, manage clinical trials, and lead global commercialization efforts with unparalleled scientific and regulatory authority.
- **Unique value:** Dr. Morley's key differentiator is the potent fusion of a scientist's deep technical acumen with a regulatory strategist's proven execution. Her Ph.D. in Cardiovascular Physiology allows her to champion complex, novel technologies with exceptional scientific credibility before regulatory agencies like the FDA. This unique combination makes her an incredibly effective partner for companies commercializing innovative devices that face the highest regulatory hurdles.
- **Ideal projects:** The ideal client for Dr. Morley is a startup or small-to-medium-sized enterprise developing a novel, high-risk medical device, especially a Class III implantable cardiovascular product or a complex IVD. Companies seeking a strategic partner for their entire regulatory journey—from initial pathway assessment and Q-Submission strategy to clinical trial management and PMA authoring—will find her expertise invaluable. She is perfectly suited for projects requiring a Breakthrough Device Designation or navigating a challenging De Novo or PMA pathway for the first time. Engaging Dr. Morley early in the development process is optimal for companies needing to build a robust regulatory and clinical strategy from the ground up for U.S. and global market success.
- **Last analyzed:** Thu Jan 01 2026 21:36:21 GMT-0500 (Eastern Standard Time)
---
### **Qualifications & scope**
- **Submission types:** 510k-traditional, pma, clinical-trials, qms, international
- **Device classes:** class-iii, class-ii
- **Specialties:** cardiovascular, hematology, pathology, clinical trials, quality system implementation, quality management systems, risk management, regulatory strategy, other
- **Device panels:** cardiovascular, ivd
- **Regulatory pathways:** 510k, pma, ide, q_sub, hde, post_market, breakthrough_devices, de_novo
---
Key Highlights
- Dr. Deborah Morley offers a rare and powerful combination of deep scientific expertise and seasoned regulatory leadership, refined over 30 years in the medical technology industry. Her Ph.D. in Cardiovascular Physiology provides a profound understanding of complex device mechanisms, which she masterfully applies to regulatory strategy, particularly for high-risk Class III cardiovascular and IVD products. With an exceptional track record that includes successfully guiding 10 PMA submissions and s
- Dr. Morley's key differentiator is the potent fusion of a scientist's deep technical acumen with a regulatory strategist's proven execution. Her Ph.D. in Cardiovascular Physiology allows her to champion complex, novel technologies with exceptional scientific credibility before regulatory agencies like the FDA. This unique combination makes her an incredibly effective partner for companies commercializing innovative devices that face the highest regulatory hurdles.
Certifications & Trust Signals
- 30 years experience
- 3 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- The ideal client for Dr. Morley is a startup or small-to-medium-sized enterprise developing a novel, high-risk medical device, especially a Class III implantable cardiovascular product or a complex IVD. Companies seeking a strategic partner for their entire regulatory journey—from initial pathway assessment and Q-Submission strategy to clinical trial management and PMA authoring—will find her expe
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, Pre-Sub / Q-Sub
Device Types Supported:
IVD, Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
30
Num510k Submitted:
3
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
cardiovascular, ivd
Technology Types:
implantable, ivd_test
Engagement Models:
hourly
Accepting New Clients:
No
