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 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.

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, risk