September 29, 2021
3:00-4:00 PM EST
This presentation will include an overview of medical device regulations and how risk plays a prominent role in product development, research and regulatory submission and will include an overview of regulatory history, device classification, scientific evidence, premarket submission and postmarket surveillance.
Kathi is Executive Director of the Central New York Biotech Accelerator (CNYBAC), a 50,000+ square foot state-of-the-art multi-use facility located in Syracuse, NY. CNYBAC, a NYS Certified Business Incubator operated by SUNY Upstate Medical University, licenses wet labs to accepted startup companies commercializing biotech technology. Kathi manages facility operations, business development, client resource matching, grant submission, and program development such as the annually-held grant supported Medical Device Innovation Challenge, now in its 5th year. Kathi also mentors many early stage biotech innovation teams regarding regulatory strategy, customer discovery, startup process, clinical trials and state-based resources available to assist commercialization needs. Kathi serves as a Board Member for both MedTech, New York State’s biomed trade organization, and the Business Incubator Association of New York State (BIANYS) and is an Adjunct Assistant Professor at Upstate Medical University. Kathi is a Good Clinical Practice (GCP) Regulatory Certification Instructor and Device Conference Chair for the Society of Clinical Research Associates (SOCRA). Ms. Durdon previously managed the Clinical Affairs team at Welch Allyn, a medical device manufacturer now owned by Hill-Rom.