Software and Cybersecurity Risk Management for Medical Devices
8:00 a.m. – 8:30 a.m. |
Registration and Continental Breakfast |
8:30 a.m. – 9:00 a.m. |
Welcome and Introductions |
9:00 a.m. – 10:00 a.m. |
Software Characteristics Comparing to Hardware
FDA’s Analysis of Software Recalls
|
10:00 a.m. – 10:15 a.m. |
Refreshment Break |
10:15 a.m. – 11:00 a.m. |
Overview of FDA Software & Cybersecurity Related Guidance
|
11:00 a.m. – 12:15 a.m. |
Overview of Software & Cybersecurity Related Standards
|
12:15 p.m. – 1:15 p.m. |
Lunch |
1:15 p.m. – 2:15 p.m. |
Risk Analysis for Medical Device Software
|
2:15 p.m. – 3:15 p.m. |
Group Exercise and Review With Instructors – Risk Analysis for Medical Device Mobile Apps |
3:15 p.m. – 3:30 p.m. |
Refreshment Break |
3:30 p.m. – 4:30 p.m. |
Risk Assessments and Risk Controls for Medical Device Software
|
4:30 p.m. – 5:30 p.m. |
Group Exercise and Review With Instructors – Risk Controls for Software Hazards |
5:30 p.m. |
End of Day One |
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