Easing FDA 501(k) Premarket Submissions

Global Technology Resources, Inc. (GTRI) and Integra Systems Inc. officials announce a professional services partnership agreement to assist manufacturers of wireless-enabled medical devices before and during the U.S. Food and Drug Administration (FDA) 510(k) premarket submission process.

The recent FDA guidance around wireless technology in medical devices could not have come at a more opportune time, said Vince Varga, business development manager for mobility at GTRI. Leveraging our partnership with Integra, several decades of knowledge in wireless technologies and extensive experience with medical OEMs, we have the right mix of people, tools, process, and experience to make a significant and positive impact on the medical device industry, allowing them to reduce both time to market and risk.

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, says David Hoglund, president of Integra Systems. Providing ample test results (to the FDA) showing how an OEMs 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.