Over the past ten years Integra Systems, Inc. has performed testing services for a wide variety of medical device companies. This testing has had two components; ecosystem network testing for a WLAN enabled medical device and wireless-co-existence testing.
We have provided a very structured process of the authorship of a test plan and protocol, the actual testing, and the detailed end results. The end product provided has allowed companies to meet the requirements as stated in the attached document. (Radio Frequency Wireless Technology in Medical Devices – Guidance for Industry and Food and Drug Administration Staff – Document issued on: August 14, 2013)
In addition, the output documentation of this testing has provided a foundation for the proper field deployment.
