Founder and Principal Consultant
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 quali...
Experience: 25+ years
JARRELL T.D. MCWILLIAMS provides regulatory consulting services to clients in:
Possesses a Bachelor of Science in Electrical Engineering from the University of Pittsburgh, providing a strong foundational understanding of the technical principles underlying medical devices. This engineering background is invaluable for comprehending complex device functionalities, safety features, and the technical intricacies of regulatory submissions. Their education equips them to effectively bridge the gap between engineering design and regulatory compliance in the medical technology sector.
Holds multiple U.S. patents for fluid injection systems, demonstrating a capacity for innovation and technical contribution within the medical device field. This patent history underscores a deep engagement with product development and a commitment to advancing medical technology.
Brings over 25 years of extensive experience in the medical device industry, including significant senior leadership roles at Bayer U.S. in Research and Development and Quality. Demonstrated success in directing cross-functional teams, redesigning product development processes for regulatory alignment and flexibility, and overseeing strategic planning for 510(k) submissions. Proven expertise in managing R&D Quality, ensuring adherence to global standards, and leading compliance initiatives for product portfolios. Their career progression highlights a deep understanding of the product lifecycle from development to compliance.
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. Prov...
With 25 years of experience, this consultant specializes in navigating complex FDA, EU MDR, and global regulatory landscapes for medical devices. Their regulatory expertise depth is demonstrated through successful management of multiple 510(k) submissions and adherence to EU Medical Device Regulations. This consultant boasts an impressive track record of ensuring regulatory compliance, product safety, and successful product clearance. Their strong foundation in engineering design and regulatory compliance, as well as experience in managing R&D Quality and leading compliance initiatives, equips them to effectively bridge the gap between engineering design and regulatory compliance. This expert's expertise in ISO 14971 for Risk Management, FDA 510(k) and EU MDR submissions, and IEC 60601 series for device safety and EMC testing further solidifies their value proposition for medtech companies. Their ability to develop Design Documentation, conduct Gap Analysis, and implement Risk-Based Processes makes them an invaluable asset for ensuring regulatory compliance and product safety.
This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.
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