Senior Principal Regulatory Consultant
NAMSA
Selby, England, United Kingdom
Jane Arnold-Round has over 30 years experience in the medical device industry working with a broad range of medical device technologies and organisations from start-ups to multinationals. She was a Notified Body reviewer for over 15 years having worked for BSI as a medical device product specialist with particular responsibility for the woundcare sector, device-drug combinations and medical device utilising animal tissues. A regulatory consultant for 20 years, she joined the medical device consulting team at NAMSA in 2018. In addition, she is the convenor of the ISO/TC194/WG19 Committee on Tissue Product Safety and an active Member of the ISO/TC194 Committee on Biological Evaluation of Medical Devices.
Jane has a focus on complex submissions for high risk devices, including: development of regulatory and clinical strategies and MDR transition strategies; design dossier and technical file compilations; device-drug consultations; clinical evaluations; and regulatory due diligence.
Jane works regularly with clients of borderline products to prepare regulatory strategies, classification rationales and systematic literature reviews to identify supporting scientific evidence for modes of action. She also has extensive experience in preparing medicinal substance consultation submissions including transitional submissions for the MDR as well as new products. Projects have included submissions to MEB, MPA, ANSM and MHRA.
Disclosure information not submitted.
Device - Drug Borderlines – Challenges in Europe and the USA
Friday, May 16, 2025
11:45 - 12:45 CEST