About the webinar
Gadi Ginot will share useful tips for a successful pre-sub to the US FDA. Pre-sub is a mean to solicit early feedback from the US FDA on the regulatory path and understand the FDAs expectations from the future submission. An effective pre-submission process can streamline FDA review. However, pre-sub can be unproductive and often times result in more questions than answers. Physio-Logic has been called in many time to help submitters reverse counterproductive pre-subs that ended with FDA imposing regulatory requirements that were very burdensome. Gadi will share his insights and discuss the do’s and don’ts of pre-sub leveraging his 27 years’ experience in negotiating successfully with the US FDA.
Anthon will then discuss the sesign of connectors and accessible parts to IEC 60601-1 requirements. His talk will address common issues related to the use of connectors in active medical equipment. He will tackle common questions such as “Is it ok to leave charging port uncovered”? “Can we have parts with voltage accessible”? And more…
Gadi Ginot is the founder of Physio-Logic Ltd, Israel’s largest and leading provider of accelerated medical device approval, certification and regulatory compliance solutions.
He is internationally renowned for his leadership in medical device regulations. What sets Gadi apart from other regulatory professionals is his multi-disciplinary education in science, business and medicine, knowhow and hands-on experience mastering both medical device regulation, quality assurance and clinical trials. This synergy powers the innovative regulatory strategies that paved the path to market in the USA, the EU and the Far East of many innovative device within unprecedented time lines boosting return on investment (ROI).
Gadi brings forward over 27 years’ experience in the biotech industry, from entry to the VP level, residing in three continents (EU, US, Israel), serving global corporate as well as start-ups. His track record include over 50 expedited device approvals, at record times, negotiating successfully the US FDA, Notified Bodies and Israeli MOH to accept out of the box regulatory and clinical strategies. Gadi is a sought-after lecturer and mentor in numerous prestigious academic programs, accelerators and hubs.
Anthony Nikitin, Expert Safety Engineer, ITL Ltd.
Experienced in various compliance disciplines with a specialty in Medical Device compliance and global market access. He is an expert in the application of IEC 60601 family standards, ISO 14971 and related standards. Anton supports submissions to regulatory bodies, reviews and audits and provides guidance and training for manufacturers on safety and EMC testing in compliance with the 4th edition of IEC 60601-1-2.