GTRI and Integra Partner to Ease FDA 510(k) Premarket Submissions for Wireless-enabled Medical Device Manufacturers
by Zivaro, on Aug 21, 2013 6:30:53 AM
Denver, Colo. – August 21, 2013 – Global Technology Resources, Inc. (GTRI) and Integra Systems, Inc. today announced 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,” 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.”
Learn more about the GTRI and Integra healthcare solutions at http://gtri.wpengine.com/markets-served/health-care-information-technology and http://www.integrasystems.org.
GTRI provides industry-leading consulting and technology services that help clients derive real business value from their technology investments. With deep foundations in both networking and data center technologies, we support clients across a broad spectrum of industries with IT strategy, planning, private and cloud architectures, implementation and IT operations. Learn more at http://gtri.wpengine.com/.
About Integra Systems, Inc.
Integra Systems is a full-service global-reach healthcare, medical device, and RF engineering centric consultancy. Medical device OEMs and Health Care Delivery Systems have come to rely upon our thirty years of experience coupled with hands-on field experience in the wireless and mobility space. We combine our wireless domain and clinical process experience to address our clients’ critical needs, spanning all areas of healthcare wireless (WLAN/PAN), distributed antenna systems, cellular, PCS, Public Safety, LTE, and RFID/RFLS.
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GTRI is a registered trademark of Global Technology Resources, Inc. Other company and product names may be trademarks of their respective owners.
Global Technology Resources, Inc.
Integra Systems, Inc.