Kristin Miller
Kristin Miller Obstetrics & Gynecology, PLC
RN, CCRC | Med Device & Pharma Law Expert | Clinical Trial Leader | Regulatory Submissions Specialist
Highly accomplished Registered Nurse and Certified Clinical Research Coordinator with a robust background in cardiovascular and neurodegenerative disease research. Possesses advanced education including a Masters in Jurisprudence with a focus on Pharmaceutical and Medical Device Law, demonstrating a deep understanding of regulatory compliance. Proven expertise in leading complex clinical trials, managing regulatory submissions (including Emergency Use Authorization and Single-Use INDs), and ensuring adherence to all applicable federal clinical trial programs. Skilled in protocol development, patient recruitment, data management, and adverse event handling. A published author and mentor, dedicated to advancing medical research and patient care, with a strong ability to navigate intellectual property and foster collaborations.
HQ:
Memphis, United States
Languages:
English
Timezones:
EST
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, 510(k) Strategy & Authoring, Traditional 510(k) Support, Special 510(k) Support, Abbreviated 510(k) Support, Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C), Labeling Review for Submission (510(k)/De Novo/PMA), Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k), De Novo, PMA, Pre-Sub / Q-Sub
Device Types Supported:
Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
25
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
cardiovascular, neurology
Accepting New Clients:
Yes
Supports Estar:
Yes
Supports Labeling Review:
Yes
Provides Submission Project Management:
Yes
