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.
Meet our Moderator and Panel
Etienne Nichols, Medical Device Guru and Mechanical Engineer
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
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.
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We encourage registering early. Seating is limited. For more information, please contact Nancy.Richardson@VOCcompany.com