http://www.gtri.com/news/gtri-and-integra-partner-to-ease-fda-510k-premarket-submissions-for-wireless-enabled-medical-device-manufacturers-2/
The collaboration between Integra and GTRI brings together five distinct but equally significant domains important to the success of mobile medical device operation in a healthcare environment:
•FDA premarket submission and risk management consulting
•Electromagnetic compatibility testing
•Wireless performance and security testing including medical device deployment guidance
•Medical device testing in real-world situations
•High-quality wireless local-area network (WLAN) assessment, design and deployment services at the healthcare facility to support critical applications
“Wireless networks, specifically WLANs, are ubiquitous in healthcare facilities due to their evident utility in providing a stable, shared network infrastructure to support medical systems that reduce errors, decrease caregiver response times and increase worker efficiencies through better collaboration,” said David Hoglund, president of Integra Systems. “Providing ample test results (to the FDA) showing how an OEM’s specific medical device can operate consistently, securely, reliably and at low risk to the patient and organization takes diligent planning, test execution and complete documentation. That’s where the Integra and GTRI partnership benefits our clients.”
