by dhoglund@integrasystems.org | Jan 5, 2022 | FDA 510(k)
Integra Systems, Inc. has assembled a world-class team that has enabled a medical device company to complete an initial FDA 510(k) submission in 2021. This was completed on time and included a vast array of services. These services included EMC/EMI testing, wireless...
by dhoglund@integrasystems.org | Aug 13, 2013 | FDA 510(k)
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...
by dhoglund@integrasystems.org | Dec 30, 2011 | FDA 510(k)
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...
