Navigating FDA’s New Cyber Device Paradigm - Cybersecurity and Compliance, Sharing Industry Best Practices
Monday, October 30, 2023 (11:00 AM - 12:00 PM) (EDT)
The evolving landscape of medical device cybersecurity regulations calls for a comprehensive understanding of the new FDA cyber device paradigm. Join our exclusive webinar where experts will delve into the intricacies of compliance and cybersecurity, providing valuable insights into best practices for designing, developing, and maintaining cybersecure medical devices.
We’ll explore, "Best Practice Development for the New FDA Cyber Device Paradigm." Our experts will guide you through the essentials of the new FDA cyber device criteria and its impact on your software/system development procedures and maintenance lifecycle.
We’ll journey through the product development and risk management lifecycle and learn about pre and post market cybersecurity risk management including, threat modeling, creating, updating, and monitoring software bill of materials (SBOM), vulnerability assessments, effective coordinated vulnerability disclosure strategies, and developing practices to avoid the new gotcha elements within the regulation.
Don't miss this chance to enhance compliance, cybersecurity practices within your organization and bring more secure devices to market.
Register now to secure your seat.
Chief Executive Officer
With an unwavering commitment to improving healthcare globally, Garret Coady combines deep expertise in SaMD & SiMD with a passion for patient-centric solutions. Under his guidance, BBT continues to make waves in the industry, empowering healthcare providers, patients, Pharma & Medical Device players alike with cutting-edge technology and a commitment to better health for all.
BBT is an established global leader in full life cycle Software and Artificial Intelligence (AI) as a Medical Device development and commercialization.
Joe’s career prior to Nova Leah spanned nearly 3 decades in the medical device industry. Primarily working with medical device manufacturers at the forefront of global market entry with two of the global leaders in applied safety science.
Before joining Nova Leah, Joe was part of the leadership team at UL Solutions where he honed his expertise in partnering with medical device manufacturers. His contributions have facilitated the successful launch and global market access of a myriad of cutting-edge technologies and innovations into the market.
In his current role at Nova Leah, Joe continues to be a guiding force, collaborating closely with numerous medical device manufacturers. He's dedicated to assisting them in adapting seamlessly to the evolving FDA cybersecurity requirements for medical cyber devices, ensuring their products meet the highest standards of safety and compliance.
Catherine McEnroe is Nova Leah’s Customer Success Manager. Catherine joined Nova Leah in 2019 and initially held the role of Quality Manager. In her role as Quality Manager, Catherine implemented an integrated management system with the overall goal of to meet the requirements of ISO27001:2013 and ISO9001:2015, which Nova Leah achieved in September 2019. Prior to working with Nova Leah, McEnroe spent over twenty-five years with Bose Corporation, where she held various roles within the quality division, most notably as Quality Manager for the Bose Corporation Ireland manufacturing facility for close to 15 years. As Nova Leah’s Customer Success Manager, Catherine works with Nova Leah’s customers, helping them to get maximum value from the company’s range of risk management solutions.