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.
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:
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
