FDA's Medical Device Software Regulation

This training program will focus on FDA software guidance. It will elaborate on applying current provisions that NIST (National Institute of Science and Technology) has put forth in recent reports that FDA will integrate into its regulatory oversight as well.

Why Should You Attend:

The growth of the medical software industry outpaces how FDA's regulatory process is designed. How can you anticipate and defend against the malicious remote hacking and shut down of an insulin infusion pump? In some instances, clinicians have weighed the risk of software failure against the benefits of using a device at all. You need to understand and apply the current provisions that NIST has put forth in recent reports that FDA will integrate into its regulatory oversight.

Device software is often used in conjunction with other software-based devices, but their interoperability was never anticipated. 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?

These issues will be highlighted during the webinar. The issues require careful consideration, given that no obvious answer appears at hand.

Areas Covered in the Webinar:

• FDA software guidance
• National Institute of Science and Technology guidance reports
• Cybersecurity
• Interoperability
• Mobile apps
• Software validation
• Software recalls

Who Will Benefit:

• Regulatory Affairs
• Quality Assurance
• Software Design Engineers
• Manufacturing
• Complaint Dept.
• Hospital Risk Dept.