| Presenter: Edwin Waldbusser, BSME, MBA, ISO 9000 Lead Auditor Date: Tuesday, 08 December, 2026 Time: 3 pm ET | 2 pm CT | 1 pm MT | 12 pm PT Duration: 60 minutes |  |
Course Description
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. Concepts from the 2026 Guidance will be explained. The cybersecurity program must be carefully planned and documented. Required documentation will be described including the Software Bill of Materials (SBOM). A threat model, including STRIDE analysis, must be developed. A formal security risk analysis must be conducted for each risk, as well as a safety risk. Security risk must flow into Safety risk analysis. Description of cyber risks, as part of Transparency, must be transmitted to device users. Post-market monitoring and updating will be explained.
Learning Outcomes
FDA Regulation
Threat Analysis
Vulnerability Analysis
STRIDE Analysis
Exploitability and Impact Analysis
User Responsibility
Transparency to Users
Areas Covered in the Session
FDA Guidance, Regulation and legislation
Cybersecurity plan
STRIDE analysis: Risk-based analysis, vulnerabilities, threats, and threat modeling
Software Bill of Materials
Risk communication to users, updating process transparency requirements
Documentation requirements
Post-market requirements
Interactive Live Q&A Session
Recommended Participants
Company management
IT personnel
Development Engineers
Production Management
QA/ QC personnel
Software developers
Cybersecurity, ISAO, Risk
About the Presenter
Ed retired from industry after 27 years in management of development of medical device products and development of company Quality Systems.
He has been a consultant for the last 10 years, working with companies from startups to Fortune 100 in the US, Germany, United Kingdom, Netherlands, Canada, Poland and Saudi Arabia.
He specializes in Design Control, Risk Analysis, Human Factors, Software Validation, Cybersecurity, and Supplier Qualification/Control.
Ed has a B.S. Mechanical Engineering from NYU and a M.B.A. from Drexel University. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness network. He has 5 issued patents.
Additional Information
After Registration:
After registering, you'll receive a confirmation email with your unique login details and access to presentation materials. All documents are downloadable and ideal for team training or reference.
System Requirement:
- Internet Speed: Preferably above 1 Mbps
- Headset: Any decent headset and microphone which can be used to talk and hear clearly
Can't Listen Live?
No problem. You can get access to an On-Demand webinar. Use it as a training tool at your convenience.For more information, you can reach out to the below contact:
Toll-Free No: 1-302-444-0162
Email: training@skillacquire.com
Address: 651 N. Broad Street, Suite 206, Middletown, DE 19709
After registering, you'll receive a confirmation email with your unique login details and access to presentation materials. All documents are downloadable and ideal for team training or reference.
- Internet Speed: Preferably above 1 Mbps
- Headset: Any decent headset and microphone which can be used to talk and hear clearly
No problem. You can get access to an On-Demand webinar. Use it as a training tool at your convenience.
Toll-Free No: 1-302-444-0162
Email: training@skillacquire.com
Address: 651 N. Broad Street, Suite 206, Middletown, DE 19709