Medical devices using the software are similar to other computer software and systems; they can be vulnerable to security breaches, potentially impacting the safety and effectiveness of the device. It is essential that companies establish a program where they identify, analyze and control cybersecurity risks for both pre market and post market. The cybersecurity program established must be carefully planned and executed.
A formal hazard analysis must be conducted for each risk which must be communicated 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 a top priority to the FDA. Two guidance’s have been released by the FDA 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