MANUELA GAZZARD
“ Our main concern lies with customers who have never engaged with a notified body before because their products have not previously fallen under its regulations ”
MANUELA GAZZARD PRESIDENT , REGULATORY SERVICES , BSI
safety and transparency . When regulatory mandates come into effect , these companies will be in a strong position to undergo scrutiny by AI-notified bodies .”
Implications of AI regulation on customers : Navigating the transition As Gazzard highlights , there are several potential challenges faced by customers unfamiliar with working with notified bodies , particularly startups venturing into regulated domains . The transition to AI regulation may pose hurdles , necessitating early engagement and preparedness to avoid disruptions to innovation .
“ There are customers already working with notified bodies at the moment . For them , it ’ s essentially an extension , as they are familiar with the process of working with a notified body ,” she explains .
“ Our main concern lies with customers who have never engaged with a notified body before because their products have not previously fallen under its regulations .”
MANUELA GAZZARD
TITLE : PRESIDENT , REGULATORY SERVICES
COMPANY : BSI
Dr Manuela Gazzard was appointed in July 2018 , having joined BSI in April 2017 to head up its healthcare sector strategy as Managing Director of Healthcare . Manuela has over twenty years of leadership experience in the global life sciences sector including pharmaceuticals , medical devices , biotech , and other related fields . Her extensive experience includes positions as Managing Director , NovaPrep and Lab Services at Novacyt ; Group Commercial Director , Johnson Matthey / MacFarlan Smith ; and Director positions at Johnson & Johnson / Janssen and Boehringer Ingelheim . Manuela worked internationally in cancer research prior to her corporate career .
140 May 2024