The Healthcare and Enterprise Wireless Experience

Radio Frequency Wireless Technology in Medical Devices FDA Guidance Finalized Document

The DRAFT document January 3, 2007 has become a finalized document on
August 14, 2013.

Radio Frequency Wireless Technology in Medical Device
Guidance for Industry and Food and Drug Administrative Staff

Please pay special attention to pages 6-18. This goes into great detail about the validation and verification of wireless enabled medical devices in terms of quality of service testing, wireless co-existence testing, security validation and verification, and continued device life cycle maintenance.

Integra Systems, Inc., has been a strong advocate of all of this for years as well as we have employed these methods and practices for device companies on a global basis. It is our belief that these are the defined best practices for the medical device industry at large and that there should be methodologies in place for design, testing, and device life cycle maintenance. We have helped several companies on a global basis down this multi-faceted testing path as well as written several copyrighted test plans and protocols surrounding all of the aforementioned. Finally; we have conducted the testing to ensure compliance with the now released document. Our process and methods have allowed many wireless enabled devices from companies achieve a very rapid approval process.

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Medical Design for Regulatory Compliance

Designing products for regulatory compliance can eliminate surprises! How do you move through this maze? Today I had a great conference call with my old friend of many years, Bill Salzstein. Once we got caught up, we shared ironically same stories about how medical device companies tend to look at the 510(k) process. I can attest to this of what I went through this year,it is how you look at the whole risk mitigation piece in light of the reviewer that can have the ultimate impact on the timeliness of the approval process. Here is the excerpt article that Bill sent to me that is a good read.
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