Medical Device Cybersecurity Following Latest FDA Guidance
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. This webinar will describe a program that will be compliant to the FDA requirements
Why you should 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 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 Exceptions
Who Will Benefit:
Company Management
IT Personnel
Development Engineers
Production Management
QA/ QC Personnel
Software Developers
Cybersecurity, ISAO, risk
Speaker Profile
Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.
Event link:
https://www.compliance4all.com/webinar/--502939LIVE?channel=theconferencealerts_2020_SEO
Contact Info
Netzealous LLC, DBA -Compliance4all
Email: [email protected]
Phone: +1-800-447-9407
Website: https://www.compliance4all.com/
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 you should 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 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 Exceptions
Who Will Benefit:
Company Management
IT Personnel
Development Engineers
Production Management
QA/ QC Personnel
Software Developers
Cybersecurity, ISAO, risk
Speaker Profile
Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.
Event link:
https://www.compliance4all.com/webinar/--502939LIVE?channel=theconferencealerts_2020_SEO
Contact Info
Netzealous LLC, DBA -Compliance4all
Email: [email protected]
Phone: +1-800-447-9407
Website: https://www.compliance4all.com/
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