When: |
28 Nov through 28 Nov 2018 | |
Where: |
Online Event | United States | |
Website URL: |
https://www.compliancetrainingpanel.com/Webinar/Topic?WB=MD00118 | |
Categories: |
Life Sciences - Other |
Keywords:
Event description:
Description :
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. This webinar will describe a program that will be compliant to the FDA requirements.
Why :
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 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...
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Posting date:
15 November 2018 | 188 views
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