WHY ATTEND?
There is no Silver Bullet solution to the SBOM, cybersecurity, and compliance challenges. These webinars are designed to arm you with critical information to support you and your organization on the journey.
Global and domestic Medical Device Manufacturers have more questions than answers. Much is evolving – FAST. Successful compliance dramatically impacts all leaders at Medical Device Manufacturers.
- Urgent – FDA’s new SBOM regulatory mandate goes into effect on October 1st, 2023
- Impact – All leaders at Medical Device Manufacturers will face change related to these requirements
- Critical – Successful compliance is dependent on inter-departmental collaboration
Upcoming Webinars
-
“Avoid RTA (Refuse to Accept) with the Right Medical Device Cybersecurity Strategy”
September 13th, 2023 12:00 – 1:00pm EST
Join us for a discussion on best practices related to the looming deadline of October 1st, 2023, as noted in the Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act/Guidance for Industry and Food and Drug Administration Staff.
Meet our Moderator and Panel
| Etienne Nichols, Medical Device Guru and Mechanical Engineer Greenlight Guru Etienne has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project Management Professional (PMP) certification. Etienne understands the pain of following the Design Controls process in paper-based QMS environment. His expansive knowledge, experience, and passion with medical devices is evenly matched with how much he enjoys helping customers work efficiently through the design and development process to bring safe, high-quality products to market. |
| Shawnnah Monterrey, CEO & Founder Beanstock Ventures, An FDA® Accredited 510(k) 3rd Party Review Organization An industry authority who founded BeanStock Ventures after nearly a 20-year career as a technical leader. Shawnnah was responsible for developing strategies and leading complex global product development programs and functional management of software and software quality assurance departments for both startup and mature organization with emphasis on the development of medical instruments, life science, diagnostics, clinical applications. |
| Elisabeth George, CEO & Founder Elisabeth George Consulting, LLC Elisabeth is an experienced transformational leader who sets strategies across the TOTAL product life cycle. She has shaped and led global organizations in continuous improvement through innovative ways of utilizing standards and regulations. Elisabeth has held ascending leadership roles at Phillip’s, which evolved to global responsibility for Quality, Regulatory, Sustainability and Product Security. Elisabeth is recognized via several awards for her dedication, and now serves on ANSI’s board of directors. |
| Ken Zalevsky, Panelist, CEO & Founder Vigilant Ops Ken is a highly regarded certified Cyber Security Leader, with certifications and related disciplined degrees from Carnegie Mellon & Harvard Universities. Ken led Medical Device Cybersecurity at Bayer and has over 19 years of experience in the medical device industry. He has served as a trusted cybersecurity consultant to national and international healthcare industry stakeholders, including the FDA & Department of Homeland Security. Ken is the founder and CEO of Vigilant Ops, Inc. which helps medical device manufacturers to manage their cybersecurity SBOM and vulnerability monitoring/management needs across the enterprise. |
STAY TUNED FOR FUTURE WEBINAR ANNOUNCEMENTS!”
Missed One? View the Replay Here!
We encourage registering early. Seating is limited. For more information, please contact Nancy.Richardson@VOCcompany.com