Medical Device Cybersecurity Following New FDA Guidance

This training will discuss the final guidance on postmarket management of cybersecurity in medical devices which was released in Dec. 2016. Attendees will learn how to establish a risk-based framework for assessing when changes to medical devices for cybersecurity vulnerabilities require reporting to the FDA.

Why Should You Attend:

Medical device cybersecurity has become very important to the FDA. They have issued two recent 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. The company must establish a program where they identify, analyze and control cybersecurity risks. 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.

This Medical device cybersecurity webinar will describe a program that will help you stay compliant with the FDA requirements. Additionally, it 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.

Areas Covered in the Webinar:

• 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
• Production Management
• QA/QC Personnel
• Software Developers
• Regulatory Personnel