Medical Device Cybersecurity Following Latest FDA Guidance
Duration : 60 Minutes
Edwin Waldbusser, Medical Device
Ed retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. He was involved in the development of products such as IVD devices, kidney dialysis systems and inhalation devices. His QS experience includes, design control, risk analysis, CAPA, softwa Read more
Medical devices using the software are similar to other computer software and systems; they can be vulnerable to security breaches, potentially impacting the safety and effectiveness of the device. It is essential that companies establish a program where they identify, analyze and control cybersecurity risks for both pre market and post market. The cybersecurity program established must be carefully planned and executed.
A formal hazard analysis must be conducted for each risk which must be communicated 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.
Course Objectives:
Medical device cybersecurity has become a top priority to the FDA. FDA expects a proactive extensive risk-based program to minimize risk to the user from cyber-attacks including active involvement with information sharing groups.
Course Outline:
• Cybersecurity Plan
• Risk-based Analysis
• Hazard Analysis following ISO14971
• Risk Communication to users
• Required Membership in information sharing groups
• Reporting Requirements and Exceptions
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Company Management
• IT Personnel
• Development Engineers
• Production Management
• QA/ QC Personnel
• Software Developers
• Cybersecurity, ISAO, risk
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
100% MONEY BACK GUARANTEED
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