Medical Device Cyber Security following Latest FDA Guidance

Overview:

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 with some exceptions established. This webinar will describe a program that will be compliant to the FDA requirements.

Why should you 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 involvement with information sharing groups.

Areas Covered in the Session:

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

Who Will Benefit:

• Company Management
• IT personnel
• Development Engineers
• Production Management
• QA/ QC personnel
• Software developers