In this live interactive session, we will provide an overview of U.S. FDA cybersecurity requirements for medical device and IVD submissions based on FDA guidance documents for pre-market and post-market requirements. We will also cover cybersecurity requirements for FDA eSTAR submissions.

Speakers:
Fayyaz Memon has over 30 years of regulatory, quality and clinical experience in the IVD/LDT, medical device, and biotech industries, including software, manufacturing, and operations. Fayyaz has held progressive roles at a number of companies, including Natera, Biological Dynamics, Asuragen, Qiagen, PrimeraDx, ThermoFisher, Innovative Neurotronics, Digene, Pfizer, and J&J, prior to founding AltaQ.

Scott Cady is a seasoned IT executive with over 25 years of expertise in quality, compliance, and validation within the health life sciences industry. He specializes in Computer System Validation (CSV), Computer Software Assurance (CSA), regulatory compliance (FDA, SOX, GDPR), industry standards (ISO 20000, ISO 27001, ISO 42001, ITIL, GAMP), and data integrity governance.