This proposed session focuses on practical lessons learned from FDA interactions involving software, algorithms, AI/ML, and cybersecurity in safety-critical medical devices. The webinar is targeted toward regulatory, quality, digital health, legal, and executive stakeholders involved in medical device development and commercialization. Topics include common FDA deficiencies across 510(k), De Novo, and PMA submissions; regulatory expectations for AI/ML and PCCP frameworks; software documentation and human factors issues; and cybersecurity expectations such as SBOMs, threat modeling, and postmarket management. The session emphasizes integrating regulatory strategy early in development to reduce delays and review cycles. The featured speaker, Richard Jackson, brings over 25 years of experience in safety-critical systems, AI, software validation, and FDA submissions for Class II and III medical devices.
