Integra Systems, Inc. has worked with many medical device companies helping them to validate and verify the wireless components for design, as well as to conduct the required validation and verification testing for a FDA 510k approval process.
This goes back as far as 2005 in initial work with a patient monitoring company and expanded where we have worked with many companies large and small.
Helping clients to achieve the process of the choice of the correct wireless radio and validating the performance of this in the healthcare enterprise is no easy task. We have been in around the wireless space for over thirty years and as a result of this we know something about RF co-existence.
Since we were the original thought leader behind the first ever “shared” enterprise medical device wireless network for patient monitoring; we do know something about how to validate and verify the quality of service requirements. The natural output of this was to author and provide test protocols and plans for a FDA 510k approval process that would satisfy and meet the intent of the application use model.
We also have worked with internal regulatory at companies to ensure the correct administrative process is followed and in place as well as answer questions that may come up throughout the review process from the actual reviewer.
In fact, because of our “know how”; from the start of the selection of the clinical site, writing the test plans, conducting the testing, creating the output document we were able to obtain the fastest FDA 510k approval in the history of a company…..90 days.
When you come to validate and verify a “wireless medical device” from the start (radio selection) throughout the final market acceptance and field deployment is a process.
Some of our clients include
www.draeger.com
www.smiths.com
www.carefusion.com
www.covidien.com
www.soterawireless.com
So at the end of day, is much more about claiming you are testing house. It is the decades of healthcare and wireless experience, multi-mode wireless domain knowledge, “actual field experience” and know how in this space that counts.
