FDA's Medical Device Software Regulation Strategy

Key Topics

• Understanding FDA legal authority
• Applying FDA classifications / risk controls
• Understanding FDA and NIST software guidance
• Identifying the quality system regulation for risk management, software verification and validation
• Identifying cybersecurity issues and developing a planned response
• Identifying and resolving interoperability issues
• Figuring out the scope of FDA’s mobile apps regulation
• Learning about bug updates classified as recalls by FDA
• Future device software applications

Who should Attend

• Quality Assurance Managers
• Regulatory Affairs Managers
• Manufacturing Managers
• Software Design Engineers
• Hospital Risk Department Personnel
• Compliance Department Personnel
• IT Security Managers
• Software Program Marketers
• Marketing Personnel