Challenging designs completed on-time and on-budget
Heart pump electronics and software
Client Challenge
Deliver ultra-reliable firmware and hardware modifications needed for FDA submission
VOLER SOLUTION
Wrote all software; revised hardware
Wrote verification protocol
Executed verification
Created doc package
In 510(k) FDA had no questions on submission
Class III device
Voler wrote all the firmware and software for a heart pump. It includes screens like this, showing how to set up the system. It also includes about 100 error messages.
There are three levels of control for safety. The user interface software in the picture can fail, and the control firmware will continue to operate the pump. If the firmware were to fail, a CPLD will keep the pump running at the last set speed.
Voler did the verification testing of the software. When this class III device was submitted to the FDA they had no questions about the software. This level of success is very unusual, although we repeated it when a second version went through verification and resubmission. Again the FDA had no questions about the software.
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May 28, 2020, 1:30 PM Pacific
Meet-up: IoT Needs Secure Messaging
Security & Privacy should be primary concerns in the design of how data flows within IoT. However, current IoT communication protocols are lacking. This talk explores how secure messaging, decoupled from the transport layer, can lead to significant wins in security, privacy & even interoperability.
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