webinar will cover FDA's evolving position on medical device cybersecurity. The
FDA has been increasing its focus on this issue, issuing guidance documents in
2014, 2016, and 2018. A draft in 2022 was followed by formalized guidance in
September 2023. This new guidance is an update, expanding on what the FDA
expects regarding proactive risk management. We'll go over the key points and
what they mean for your organization, including how the new guidance
distinguishes between security risk and safety risk.
Covered in the Session:
latest guidance, regulation, and legislation.
a comprehensive cybersecurity plan.
risk-based analysis, including identifying vulnerabilities, threats, and threat
and implementing the Software Bill of Materials.
risk to users.
process for ongoing cybersecurity maintenance.
Should You Attend?
for medical devices is getting more attention from the FDA. A new guidance
document was issued in 2023, and it has important updates that you need to know
about. This guidance comes with the backing of new federal legislation, giving
the FDA more power to enforce these rules. We'll cover what the new guidance
says, what's changed, and what you should be doing about it.
webinar is crucial for individuals and entities involved in the medical device
IT and cybersecurity professionals.
device product developers.
officers and regulatory professionals in the healthcare industry.
control professionals in the medical device industry.
professionals concerned with device security.
- Policymakers and regulators focusing on healthcare cybersecurity.
- Consultants in the medical device and healthcare industry.
Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 11 years.
Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.