GTRI, Integra Systems Partner to Help Medical Device Manufacturers Navigate FDA Process; David Hoglund Comments

GTRI logo_GovConWireGlobal Technology Resources Inc. and Integra Systems Inc. have partnered to aid wireless medical device manufacturers in the Food and Drug Administration’s process of premarket submissions.

The GTRI-Integra Systems team will work to consolidate FDA premarket and risk management consulting, electromagnetic compatibility and wireless performance testing, as well as security and medical device assessment, GTRI said Wednesday.

Vince Varga, business development manager for mobility at GTRI, said the companies intend for the agreement to help medical device manufacturers reduce time to market and minimize risks.

The team will also design, deploy and assess wireless local-area network at the healthcare facility.

David Hoglund, president of Integra Systems, said GTRI and Integra Systems intend to show the FDA how the manufacturers’ medical devices function for patients and organizations.

“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,” he added.

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