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.
Why You Should Attend:
Medical device cybersecurity has become a top priority to the FDA. Two guidance’s have been released by the FDA 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 Should Attend:
- Company Management
- IT Personnel
- Development Engineers
- Production Management
- QA/ QC Personnel
- Software Developers
- Cybersecurity, ISAO, risk
Course Director: EDWIN WALDBUSSER
Edwin Waldbusser 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, software validation, supplier qualification/ control and manufacturing/non-conforming product programs. He now consults in the area of quality systems for medical devices with emphasis on design control, software validation, risk analysis and human factors analysis.
Ed has a B.S. Mechanical Engineering from NYU and a M.B.A from Drexel University. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness network. He has 5 issued patents.