Integra Systems, Inc. has assembled a world-class engineering, clinical, and regulatory team to bring IoT enabled wearable medical device products to the market. We have the regulatory experts that understand and have the proven experience of taking a product from the concept beginning to the end approval of the FDA 510(k) process. In addition, we have the wireless experts that have the engineering expertise that have brought unique medical medical devices enabled by different wireless capabilities to the market. References: FDA Document Final Issue 14, August 2013, ANSI C63.4-2013, ANSI C63.27-2017, AAMI TIR69-2017, AIM 7351731-2017, IEC 60601.
One of many, but a project example.
Start up medical device company in surgical instrumentation requested expertise for wireless communication. Integra Systems sourced the correct BLE SOC with the right embedded module, brought in outside expertise for regulatory requirements, conducted the required wireless testing, and finally packaged everything for submittal from a wireless and cyber security side. Company received a regulatory approval straight forward that allowed a immediate go to market opportunity.
