DIONE FULLER
Expert FDA & EU MDR Regulatory Strategist | Quality Systems Specialist | Global Market Access
Accomplished and highly skilled Regulatory & Quality Affairs Professional with 14 years of experience navigating complex global regulatory landscapes for medical devices. Proven expertise in developing and executing comprehensive regulatory strategies, ensuring seamless market access across the US, EU, and Canada. Adept at managing EU MDR, FDA 510(k), and Health Canada submissions, demonstrating a deep understanding of quality systems (ISO 13485, 21 CFR 820, MDSAP) and technical documentation requirements. Recognized for exceptional project management, cross-functional leadership, and a proactive approach to risk assessment and deficiency management, consistently delivering high-quality service and driving successful product compliance.
About
Accomplished and highly skilled Regulatory & Quality Affairs Professional with 14 years of experience navigating complex global regulatory landscapes for medical devices. Proven expertise in developing and executing comprehensive regulatory strategies, ensuring seamless market access across the US, EU, and Canada. Adept at managing EU MDR, FDA 510(k), and Health Canada submissions, demonstrating a deep understanding of quality systems (ISO 13485, 21 CFR 820, MDSAP) and technical documentation requirements. Recognized for exceptional project management, cross-functional leadership, and a proactive approach to risk assessment and deficiency management, consistently delivering high-quality service and driving successful product compliance.
Additional information
### **Additional information**
- **Type:** independent
- **Years of experience:** 14
- **510(k)s submitted (self-reported):** 30
- **Ex-Big MedTech:** Yes
- **Regions served:** US, EU, CA
- **Client types:** sme, large_medtech
- **Location:** United States (FL)
- **Availability:** available_now
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### **Cruxi analysis**
- **Strength summary:** With 14 years of experience background, this consultant specializes in medtech regulatory affairs and quality systems, boasting a robust track record of navigating complex global regulatory landscapes for medical devices. Their expertise spans FDA 510(k) and EU MDR submissions, with a proven ability to develop and execute comprehensive regulatory strategies for seamless market access across diverse regions, including the US, EU, and Canada. They possess deep understanding of quality systems (ISO 13485, 21 CFR 820, MDSAP) and technical documentation requirements, making them an exceptional asset for medtech companies seeking regulatory compliance and market access. Their exceptional project management, cross-functional leadership, and proactive approach to risk assessment and deficiency management further solidify their value. This consultant's strong expertise in EU MDR, FDA 510(k), and Health Canada regulations makes them an ideal partner for medtech companies aiming to expand their global presence.
- **Unique value:** This consultant stands out for their unique combination of deep regulatory expertise, extensive device expertise, and exceptional project management skills. Their ability to develop and execute comprehensive regulatory strategies, combined with their extensive experience in EU MDR, FDA 510(k), and Health Canada regulations, makes them a valuable asset for medtech companies seeking to navigate complex global regulatory landscapes. Their proactive approach to risk assessment and deficiency management further sets them apart, making them an ideal partner for medtech companies seeking regulatory compliance and market access.
- **Ideal projects:** The perfect medtech client for this consultant is a mid-to-large-sized company, preferably with a complex Class II or III device, seeking to expand its global presence, particularly in the US and EU. The company should be in need of expert guidance on navigating EU MDR submissions, managing technical documentation, and ensuring compliance with quality systems such as ISO 13485 and 21 CFR 820. This consultant excels in supporting companies undergoing their first submission, complex devices, or international expansion projects. Their expertise in EU MDR, FDA 510(k), and Health Canada regulations makes them an ideal partner for medtech companies looking to tackle these complex regulatory challenges.
- **Last analyzed:** Fri Dec 19 2025 23:50:21 GMT-0500 (Eastern Standard Time)
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### **Qualifications & scope**
- **Submission types:** 510k-traditional, international
- **Device classes:** class-i, class-ii, class-iii
- **Specialties:** software-samd, ophthalmic, dental, cardiovascular, general-hospital, regulatory strategy, risk management
- **Device panels:** cardiovascular, dental, ophthalmic, general_surgery, general-hospital
- **Regulatory pathways:** 510k, ide, post_market, de_novo, pma
---
- **Type:** independent
- **Years of experience:** 14
- **510(k)s submitted (self-reported):** 30
- **Ex-Big MedTech:** Yes
- **Regions served:** US, EU, CA
- **Client types:** sme, large_medtech
- **Location:** United States (FL)
- **Availability:** available_now
---
### **Cruxi analysis**
- **Strength summary:** With 14 years of experience background, this consultant specializes in medtech regulatory affairs and quality systems, boasting a robust track record of navigating complex global regulatory landscapes for medical devices. Their expertise spans FDA 510(k) and EU MDR submissions, with a proven ability to develop and execute comprehensive regulatory strategies for seamless market access across diverse regions, including the US, EU, and Canada. They possess deep understanding of quality systems (ISO 13485, 21 CFR 820, MDSAP) and technical documentation requirements, making them an exceptional asset for medtech companies seeking regulatory compliance and market access. Their exceptional project management, cross-functional leadership, and proactive approach to risk assessment and deficiency management further solidify their value. This consultant's strong expertise in EU MDR, FDA 510(k), and Health Canada regulations makes them an ideal partner for medtech companies aiming to expand their global presence.
- **Unique value:** This consultant stands out for their unique combination of deep regulatory expertise, extensive device expertise, and exceptional project management skills. Their ability to develop and execute comprehensive regulatory strategies, combined with their extensive experience in EU MDR, FDA 510(k), and Health Canada regulations, makes them a valuable asset for medtech companies seeking to navigate complex global regulatory landscapes. Their proactive approach to risk assessment and deficiency management further sets them apart, making them an ideal partner for medtech companies seeking regulatory compliance and market access.
- **Ideal projects:** The perfect medtech client for this consultant is a mid-to-large-sized company, preferably with a complex Class II or III device, seeking to expand its global presence, particularly in the US and EU. The company should be in need of expert guidance on navigating EU MDR submissions, managing technical documentation, and ensuring compliance with quality systems such as ISO 13485 and 21 CFR 820. This consultant excels in supporting companies undergoing their first submission, complex devices, or international expansion projects. Their expertise in EU MDR, FDA 510(k), and Health Canada regulations makes them an ideal partner for medtech companies looking to tackle these complex regulatory challenges.
- **Last analyzed:** Fri Dec 19 2025 23:50:21 GMT-0500 (Eastern Standard Time)
---
### **Qualifications & scope**
- **Submission types:** 510k-traditional, international
- **Device classes:** class-i, class-ii, class-iii
- **Specialties:** software-samd, ophthalmic, dental, cardiovascular, general-hospital, regulatory strategy, risk management
- **Device panels:** cardiovascular, dental, ophthalmic, general_surgery, general-hospital
- **Regulatory pathways:** 510k, ide, post_market, de_novo, pma
---
Key Highlights
- With 14 years of experience background, this consultant specializes in medtech regulatory affairs and quality systems, boasting a robust track record of navigating complex global regulatory landscapes for medical devices. Their expertise spans FDA 510(k) and EU MDR submissions, with a proven ability to develop and execute comprehensive regulatory strategies for seamless market access across diverse regions, including the US, EU, and Canada. They possess deep understanding of quality systems (ISO
- This consultant stands out for their unique combination of deep regulatory expertise, extensive device expertise, and exceptional project management skills. Their ability to develop and execute comprehensive regulatory strategies, combined with their extensive experience in EU MDR, FDA 510(k), and Health Canada regulations, makes them a valuable asset for medtech companies seeking to navigate complex global regulatory landscapes. Their proactive approach to risk assessment and deficiency managem
Certifications & Trust Signals
- 14 years experience
- 30 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- The perfect medtech client for this consultant is a mid-to-large-sized company, preferably with a complex Class II or III device, seeking to expand its global presence, particularly in the US and EU. The company should be in need of expert guidance on navigating EU MDR submissions, managing technical documentation, and ensuring compliance with quality systems such as ISO 13485 and 21 CFR 820. This
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:
SaMD, Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
14
Num510k Submitted:
30
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
Yes
Device Panels:
cardiovascular, dental, ophthalmic, general_surgery, general-hospital
Technology Types:
samd, implantable
Accepting New Clients:
No
