JARRELL T.D. MCWILLIAMS
Medical Device Regulatory Expert | 25+ Years Experience | FDA, EU MDR, Risk Management, 510(k), ISO 14971
Highly accomplished medical device professional with 25 years of experience, including senior leadership roles at Bayer U.S. Expert in navigating complex FDA, EU MDR, and global regulatory landscapes, with a strong focus on Medical Device Risk Management (ISO 14971) and ensuring patient safety. Proven ability to align product development with evolving regulatory expectations, enhance product quality, and support global compliance through specialized consulting services. Adept at risk-based process implementation, leading cross-functional teams, and driving successful product certifications and submissions.
HQ:
United States
Languages:
English
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
510(k) Strategy & Authoring, 510(k) eSTAR Preparation, Traditional 510(k) Support, Special 510(k) Support, Abbreviated 510(k) Support, 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), 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:
IVD, SaMD, Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
25
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
Yes
Device Panels:
radiology, ivd
Technology Types:
samd
Accepting New Clients:
No
Supports Estar:
Yes
Supports Labeling Review:
Yes
Provides Submission Project Management:
Yes
