The Verification step is a very important factor when understanding Design Controls. If the design does not pass the Verification Test, there could be a high risk factor. Although I have not personally encountered an incident when the design does not pass the Verification Test, a major issue that occurs within medical devices is failure of software. The software is a key component in ensuring that medical devices perform as needed. However, there are instances when there is not as much importance given to the verification. As a result, this can cause a malfunction in the software, which puts the safety of humans at risk. This can lead to recalls, and even removal of the device at times. If Verification Tests are done with the amount significance that it should be given, there are fewer chances for error.

References:
“When Medical Device Software Fails Due to Improper Verification and Validation”