Exploring the Medical Device Cybersecurity Requirements and the Impact to Your Device Development
Thursday, November 30, 2023 (1:00 PM - 2:00 PM) (EST)
In our upcoming exclusive webinar, discover the changing terrain of medical device cybersecurity regulations, and gain invaluable insights from our panel of experts. Join us for an in-depth exploration of "Navigating the New FDA Cyber Device Landscape." Our team of experts will walk you through the fundamental aspects of the updated FDA cyber device criteria and its profound impact on your software/system development protocols and the lifecycle of maintenance.
Embark on a journey through the entire product development and risk management lifecycle. Uncover the critical elements of pre-market and post-market cybersecurity risk management, encompassing areas such as threat modeling, the creation and maintenance of software bill of materials (SBOM), vulnerability assessments, effective strategies for coordinated vulnerability disclosure, and the development of practices to preempt the regulatory pitfalls.
This is a golden opportunity to fortify compliance and cybersecurity practices within your organization, ensuring the release of more secure and compliant devices into the market. Don't let this insightful webinar pass you by!
Register now to secure your seat.
Mr. Maclay is recognized as a domain expert in Silicon Valley technical consulting associations. He is President and founder of Strawberry Tree inc, dba Voler Systems, one of the top electronic design firms in Silicon Valley, which is committed to delivering quality electronic products on time and on budget.
He has spoken at dozens of events on sensors, wearable devices, wireless communication, security for medical devices, and low power design. In 2019 he wrote Highly Successful Engineering Design Projects, a book about project management available from Amazon. From 2008 to 2010 he was President of the Professional and Technical Consultants Association (PATCA). He is a senior life member of the Institute of Electrical and Electronic Engineers (IEEE) and a member of the Consultants Network of Silicon Valley. Mr. Maclay holds a BSEE degree in Electrical Engineering from Syracuse University.
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.