FDA's Medical Device Software Regulation Strategy

The growth of the medical software industry outpaces the design of FDA's regulatory process. In some instances clinicians have weighed the risk of software failure against the benefits of using a device at all. Device software is often used in conjunction with other software-based devices, but their interoperability was never anticipated.

• How can you anticipate and defend against the malicious remote hacking and shut down of an insulin infusion pump?
• Can one software program defeat the performance capability or back up safety features of another software program?
• When interoperability surface, which software manufacturer takes the lead to solve the problem and deal with proprietary software issues?

This seminar will focus on addressing these concerns and educating participants on FDA’s recent medical device software regulation strategies.

• 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

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

Note: Use coupon code < GET20 > and get 20% off on registration and this offer is not valid for with stay registration.