Medical Device Cybersecurity following latest FDA Guidance
Instructor: Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
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
Who Will Benefit:
- Company Management
- IT Personnel
- Development Engineers
- Production Management
- QA/ QC Personnel
- Software Developers
- Cybersecurity
- ISAO