Medical Device Cyber Security following Latest FDA Guidance
Duration: 90 Minutes
Faculty: Edwin Waldbusser Level: Intermediate Course ID: 1057
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