Speaker Profile

Russ Gray

President & Regulatory Scientific Advisor, Eagle Creek Engineering, Inc.

Mr. Gray has over 40 years of experience in the life science industries. He has broad experience in product development and technical management in medical devices, in-vitro diagnostic instrumentation, analytical instrumentation, and combination pharmaceutical-device products. His expertise includes product design control and risk management systems, compliance with FDA and ISO requirements, integration of these requirements with phase gate product commercialization processes, as well as regulatory submission consulting for software-intensive products.

His early career was focused on engineering, product development, and engineering management. He was a member of project teams that developed groundbreaking computer-controlled in-vitro diagnostic, analytical instrumentation, and machine-tool products. More recently, Mr. Gray has spent substantial time helping drug manufacturers enter the world of devices and combination products. Engagements in this realm include helping drug companies design part 820-compliant quality systems, developing design control and risk management systems for outsourced device development scenarios, developing global regulatory submission strategies for drug delivery devices, and developing contract manufacturing strategies for high-volume combination devices.

Mr. Gray is especially expert on leading his clients through quality system architecture, human factors engineering and high-volume medical device manufacturing challenges. His clients range from Fortune 100 corporations to start-up companies.

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FDA’s Enforcements for Mobile Medical Applications

Information provided will allow an attendee to determine if their App is a medical device, and if it is, determine the regulatory obligations the App will carry. Guidance will also be provided as to adjusting the intended use claims for an App that might take it out of the definition of a medical device. Recommendations will be provided for getting started with medical device regulations if your App is a medical device.

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