The FDA is increasingly finding alarming problems with device software, such as the continued use of aging microprocessors and platforms. How do you prevent defects, failure rates, corrective actions, liabilities and ultimately recalls from your device software?
Please join us for a can’t-miss webinar with a panel of experts who will help you understand how to prevent potential recalls and ensure safety.
Some companies are not following design controls, not conducting enough testing and failing to create thorough requirements documents. There have been a number of cases where companies have outgrown the microprocessor or software platform. Companies take shortcuts by making incremental changes, which are less expensive rather than starting from scratch with a new platform. Software problems then arise in all sorts of devices and increase the number of recalls and, in some cases, deaths.
At this exciting new webinar, you’ll learn how to assess your existing device software safety processes and ensure that you have sound risk management, quality management and good software engineering. Identify what needs to be done and documented to ensure the safety of your device!
Learn what strategies other organizations are pursuing to verify and validate their device software. Understand the design requirements outlined in the Quality System Regulation. Analyze sample recall situations to study verification and validation obstacles, and get practical, real-world advice on what it takes to implement a successful software validation program. All this, and more, is yours when you register to attend FDA Requirements for Device Software: Are You in Compliance?
The following is a sample of what will be discussed during this comprehensive 90-minute webinar:
- What the most critical components are to a software verification and validation program
- How errors are introduced into software code
- How to satisfy design control requirements for your device software using simulation, modeling and visualization techniques
- How much testing is enough
- The appropriate amount of documentation for the software you are making
- How to conduct risk analysis for device software
- When an iPhone is a medical device, and how to determine whether your software is a medical device
- How and when an electronic health record system should be regulated
Sidley is proud to co-sponsor this FDC-Windhover webinar.
Wednesday, July 22, 2009 • 2pm Eastern • 11am Pacific