Jane Arnold-Round has over 25 years of 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 medical device utilising animal tissues. A regulatory consultant for 15 years, she joined the medical device consulting team at NAMSA in 2018.
Jane has a focus on complex submissions for high risk devices, including: development of regulatory and clinical strategies, design dossier and technical file compilations, device-drug consultations, clinical evaluations, and regulatory due diligence.
Monday, September 14, 2020
12:00 PM – 1:30 PM EDT