Software and Cybersecurity Risk Management for Medical Devices
8:00 a.m. – 8:30 a.m. |
Continental Breakfast |
8:30 a.m. – 9:00 a.m. |
Latest Updates from FDA on Cybersecurity |
9:00 a.m. – 10:00 a.m. |
Cybersecurity Risk Analysis (Assets, Threats, Vulnerabilities)
|
10:00 a.m. – 10:15 a.m. |
Refreshment Break |
10:15 a.m. – 11:15 a.m. |
Group Exercise and Discussion With Instructors – Cybersecurity Risk Analysis |
11:15 a.m. – 12:15 p.m. |
Cybersecurity Risk Assessments and Risk Controls
|
12:15 p.m. – 1:15 p.m. |
Lunch |
1:15 p.m. – 2:15 p.m. |
Group Exercise and Discussion With Instructors – Cybersecurity Risk Assessments and Risk Controls |
2:15 p.m. – 2:45 p.m. |
Safety and Cybersecurity Risk Analysis Documentation for Stakeholders (FDA Reviewers, Hospitals, etc.)
|
2:45 p.m. – 3:15 p.m. |
Risk Management Completeness and Effectiveness – Introduction of Assurance Case Method
|
3:15 p.m. – 3:30 p.m. |
Refreshment Break |
3:30 p.m. – 4:00 p.m. |
Safety and Cybersecurity Assurance Case Examples
|
4:00 p.m. – 5:00 p.m. |
Post-market Safety and Cybersecurity Risk Management
|
5:00 p.m. |
Workshop Adjournment |
Who will benefit?
- Software systems design engineers and managers
- Quality, reliability and risk management engineers and managers
- Project managers involved in design and development
- Medical staff evaluating risk, safety or effectiveness
- Quality managers
- Regulatory affairs specialists and managers
- Medical device app developers
- IT systems development managers
- Contract manufacturers
- General/corporate counsel