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Medical Device Cyber Security Following 2022 FDA Pre-market Guidance
- Guidance
- Regulation and legislation
- Cybersecurity plan
- Risk-based analysis
- Vulnerabilities
- Threats and threat modeling
- Software Bill Of Materials
- Risk analysis following ISO14971
- Risk communication to users
- Updating process
- Transparency requirements
- Documentation requirements
Overview of the webinar
This webinar will explain the process of analyzing and minimizing cyber risks for premarket submissions. It will explain how cyber risks are identified and mitigated. New concepts from the 2022 Guidance will be explained. The cybersecurity program must be carefully planned and documented. The manufacturer no longer can pass cybersecurity responsibility to the network. It is now a joint responsibility. Required documentation will be described including the Software Bill of Materials. A formal risk analysis must be conducted for each risk. Communication of risks as part of Transparency must be sent to devise users.
Who should attend?
- Company management
- IT personnel
- Development Engineers
- Production Management
- QA/ QC personnel
- Software developers
- Cybersecurity
- ISAO
- Risk
Why should you attend?
Medical device cybersecurity has become very important to the FDA. They have issued three Guidance on the subject; in 2014, 2016, and 2018. In 2022 a draft Guidance was issued that would replace the 2014 and 2018 Guidances and supplement the 2016 Guidance. This draft will become a Guidance in late 2023. In 2023 federal legislation gave the FDA legal authority to enforce cybersecurity. the 2022 Guidance greatly expanded the FDA expectations for cybersecurity and gave concrete examples. FDA expects a proactive extensive risk-based program to minimize risk to the user from cyber-attacks including active involvement with information-sharing groups.
Faculty - Mr.Edwin Waldbusser
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 areas of design control, risk analysis and software validation for the past 8 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.