In this informative webinar, we delve into the critical field of medical device cybersecurity following the FDA's 2022 premarket guidance. The session provides insight into analyzing and mitigating cyber risks for premarket submissions, a task increasingly crucial in our digital age. Participants will gain an understanding of the identification and mitigation processes for cyber risks, as well as the fresh concepts introduced in the 2022 guidance. Emphasizing the joint responsibility of cybersecurity between the manufacturer and the network, the webinar underscores the need for carefully planned and well-documented cybersecurity programs. The session will also elaborate on required documentation, including the Software Bill of Materials, and the importance of formal risk analysis. Moreover, the need for risk communication as part of Transparency, directed towards device users, will be discussed in detail.
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 following ISO14971.
- Communicating risk to users.
- Updating process for ongoing cybersecurity maintenance.
- Fulfilling transparency requirements.
- Meeting documentation requirements.
Why Should You Attend?
Medical device cybersecurity has emerged as a priority for the FDA, prompting the release of three guidances in 2014, 2016, and 2018, and a draft guidance in 2022. Set to become a Guidance in late 2023, this draft seeks to replace the 2014 and 2018 guidances, while supplementing the 2016 one. Furthermore, in 2023, federal legislation granted the FDA the authority to enforce cybersecurity. The 2022 guidance significantly broadens the FDA's expectations for cybersecurity, offering tangible examples. The FDA now anticipates a proactive, extensive risk-based program to minimize cyber-attack risks to users, including active involvement with information-sharing groups.
This webinar is an opportunity to understand these changes and expectations more clearly and prepare accordingly.
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.
Tags: Cybersecurity, Medical Device, FDA Guidance, Premarket Guidance, ISO14971, Risk Analysis, Software Bill of Materials, Cyber Threats, Cyber Risk Mitigation, Risk Communication, Medical Device Webinar, Edwin Waldbusser, June 2023,