Software Risk Management

Course "Software Risk Management" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Overview:-The seminar will address the specific challenges software poses for the risk management process. Basic risk management concepts will be introduced and then applied to software specific applications. Why you should attend:
Risk Management is a regulatory and statutory requirement for medical devices. The generic procedure to perform risk management is outlined in ISO14791, however, as soon as software is used challenges arise. How to address these specific software issues and the application of FDA and IEC requirements for development of safety-critical software used in medical devices is the content of this seminar.
Who Will Benefit:
• Project managers
• Software Engineerrs
• Regulatory specialists
• Quality assurance specialists
• Documentation specialists
• Test managers
• Software team leaders and lead developers