Medical Device Cybersecurity following latest FDA Guidance

The 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 devise users.

A complex set of reporting requirements has been established. This webinar will describe a program that will be compliant with the FDA requirements.

Why should you Attend:
Medical device cybersecurity has become very important to the FDA. They have recently issued two Guidance on the subject; the latest is 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.

Areas Covered in the Session:

• Cybersecurity Plan
• Risk based analysis
• Hazard analysis following ISO14971
• Risk communication to users
• Required membership in information sharing groups
• Reporting requirements and the exceptions

• Company Management
• IT Personnel
• Development Engineers
• Production Management
• QA/ QC Personnel
• Software Developers
• Cybersecurity
• ISAO