AI/ML SaMDs: Cybersecurity, Human Factors, and Privacy
About
Date/Time
Date(s) - November 12, 202410:00 AM - 11:00 AM CT
Moving beyond the regulatory and clinical data requirements for AI/ML SaMDs, also known as Machine Learning Enabled Medical Devices (MLEMDs), this webinar goes deep into the cybersecurity, human factors, and privacy aspects of these new and challenging medical devices. AI/ML SaMDs often leverage technologies unique to them, for example, wireless connectivity and coexistence, software as a service, and mobile device-based platforms.
Learn how to design your MLEMDs from the beginning to accommodate these important features and mitigate the risks. This advanced session is designed for professionals who are ready to take their knowledge to the next level and ensure their MLEMDs meet the highest standards of regulatory and clinical excellence. Join us to stay ahead in the rapidly evolving digital health landscape!
Key Learning Points:
- Understand the FDA’s current thinking on privacy, cybersecurity, and wireless coexistence
- The CFR, GDPR, and HIPAA
- How to design your product right from the beginning, before you start any clinical trials
- How to meet FDA’s requirements for formative and summative human factors/usability testing for AI/ML SaMDs
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Speaker
Adam Saltman, PhD, MD
Principal Strategy Consultant, Clinical and Regulatory ServicesDr. Saltman is a seasoned Cardiothoracic Surgeon with over 25 years of experience, including a 12-year tenure as a Medical Officer at the U.S. FDA, where he honed his expertise in medical device introductions and regulatory compliance. With a BA from Harvard and MD/PhD from Columbia University, he’s also held prestigious roles such as Chief Medical and Regulatory Officer for two medical device companies, guiding products from conception to market. His academic contributions include serving as an Associate Professor and publishing research on Cardiac Arrhythmias and Wound Healing. A Fellow of multiple medical associations, Dr. Saltman’s core competencies lie in product development, regulatory strategy, and stakeholder engagement, with recent projects involving AI/ML devices, FDA regulatory strategies, and departmental leadership in clinical operations and medical affairs.
Monica R. Montanez, MS, RAC
Principal Regulatory ConsultantMonica has over twenty years in the medical device industry in Regulatory Affairs and Quality Assurance. Her primary focus is navigating the regulatory pathways for electro-mechanical and software driven medical devices worldwide. She has received clearance of many 510(k)s and approval of new indications for PMA device(s) of which 90% involved software. More recently, she has broadened her regulatory experience in the area of digital health that includes: Software as Medical Device (SaMD), Mobile Medical Apps (MMA), Digital Therapeutics (DTx), Artificial Intelligence (AI), Machine Learning (ML), Cybersecurity, Usability, and Risk Management. While in industry, she assisted in the development of FDA 510(k) guidance and FDA Software guidance directly with FDA.
Monica holds a Masters of Science (MS) degree in Regulatory Science (RS) from the University of Southern California (USC) School of Pharmacy. Currently, she holds Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) and Certified Quality Auditor (CQA) from the American Society for Quality (ASQ).