Overview:
This
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.
Areas
Covered in the Session:
- The
latest guidance, regulation, and legislation.
- Creating
a comprehensive cybersecurity plan.
- Conducting
risk-based analysis, including identifying vulnerabilities, threats, and threat
modeling.
- Understanding
and implementing the Software Bill of Materials.
- Applying
risk analysis.
- Communicating
risk to users.
- Updating
process for ongoing cybersecurity maintenance.
- Fulfilling
transparency requirements.
- Meeting
documentation requirements.
Why
Should You Attend?
Cybersecurity
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.
Who
should attend?
This
webinar is crucial for individuals and entities involved in the medical device
industry, particularly:
- Medical
device manufacturers.
- Healthcare
IT and cybersecurity professionals.
- Medical
device product developers.
- Compliance
officers and regulatory professionals in the healthcare industry.
- Quality
control professionals in the medical device industry.
- Healthcare
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.
Enrollment Options
Tags: FDA 2023, Medical Device, Cybersecurity Webinar, Risk Analysis, Compliance Guide, SBOM, Risk Communication, November 2023, Webinar, Edwin, Waldbusser,