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 SOC engineering support, safety testing, human factors testing, and co-existence testing. In addition we completed the instructions for use, the quick reference guide, human factor packaging design, the requirements for cybersecurity, IOT MDM services and quality management system efforts.
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