Medical Device Cyber-Security Following New FDA Guidance
Instructor : Edwin Waldbusser
Sep 13, 2017 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes
Medical device cybersecurity has become very important for the FDA. They have issued two recent guidance on this subject; the latest being 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.
It is essential for any company to establish a program where they identify, analyse and control cyber security risks. The cyber security program itself needs to be carefully planned.
This webinar by expert speaker Edwin Waldbusser will describe a program that will help you stay compliant with the FDA requirements. Additionally, Edwin will help you in formulating a formal special hazard analysis for every risk, help with strategies with communication of risks; and finally give guidance for a complex set of reporting requirements that have to be established.
- Cybersecurity plan
- Risk based analysis
- Hazard analysis following ISO 14971
- Risk communication to users
- Required membership in Information Sharing Groups
- Reporting requirements and the exceptions
Who Will Benefit:
- Engineering Personnel
- Software Developers