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.