More and more medical devices have become WLAN (802.11a/b/g), but not yet 802.11n enabled.  As a part of the validation and verification required for a FDA 510k submittal; these medical device companies are required to conduct rigorous testing processes to ensure that the WLAN enabled medical device will operate as intended. This operation is defined to ensure that the WLAN enabled medical device will operate over an enterprise WLAN network correctly; and that this adheres to the best of practices for enterprise network deployments.  These best of practices are essentially how the WLAN enabled device will operate with shared applications over a “discrete” WLAN environment.  The testing and approval of this design by either an internal letter to file or a FDA 510k submittal and approva, l ensures that the intended WLAN enabled device will not only operate as intended; but provides the most risk free wireless environment. Thus the medical device company that will offer the WLAN enabled medical device will provide the the end user the design and guidelines that will enable the healthcare client to follow the best of practices pending IEC 800001.  Several DAS (Distributed Antenna System), companies have marketed that they are able to provide WLAN enabled medical devices over their shared infrastructure.  It will be critically important to understand and have these DAS infrastructure providers obtain the validation and verification criteria (testing); either internal or external and provide this to the regulatory (FDA) submittal if deviation is made from the best of practices i.e.  discrete WLAN deployments. The salient question is will the provider of the DAS infrastructure assume the risk if a sentinel event occurs on a non-standard best of practices infrastructure design?  Will the infrastructure provider provide the documentation of validation and verification that additionally follows ISO 90001?  How will this ensure that the healthcare CIO has the documentation that will help them meet IEC 800001 guidelines pending in 2010 and 2011?