A company must establish a program where they identify, analyze and control cybersecurity risks for both pre market and post market. The cybersecurity program must be carefully planned.
A formal special hazard analysis must be conducted for each risk. Communication of risks must be sent to device users. A complex set of reporting requirements has been established. This webinar will describe a program that will be compliant to the FDA requirements.
Why You Should Attend:
Medical device cybersecurity has become very important to the FDA. They have recently issued two Guidance’s on the subject; the latest in December of 2016. FDA expects a proactive extensive risk-based program to minimize risk to the user from cyber-attacks including active involvement with information sharing groups.
- Cybersecurity Plan
- Risk-based Analysis
- Hazard Analysis following ISO14971
- Risk Communication to users
- Required Membership in information sharing groups
- Reporting Requirements and Exceptions
- Company Management
- IT Personnel
- Development Engineers
- Production Management
- QA/ QC Personnel
- Software Developers
- Cybersecurity, ISAO, risk