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Tenzing Group New Firm Provides Strategic Advice to Mobile Medical Application StartUps on Proposed FDA Regulation
Date:5/16/2013

Santa Clara, CA (PRWEB) May 16, 2013

New FDA consulting firm, The Tenzing Group, has launched an in-depth regulatory coaching service for Mobile Medical Application (MMA) startups to ensure success while understanding the costs and requirements of FDA regulation.

“For unprepared startups, FDA regulations on mobile medical applications could result in a critical obstacle or worse yet, the end to a company,” said The Tenzing Group CEO, Ryan Minarovich. “Having a mobile medical application labeled as a medical device, which is under evaluation by the FDA now, could have a significant impact on revenues and product development. Companies need to start their research early to understand the current policy landscape and how it may effect their business model as well as market strategies.”

The Tenzing Group is focused on providing clarity on FDA regulations while the industry waits for final guidance. The FDA published draft guidance mid-2011, which many agree has been too long and is causing confusion among many startup companies.

"We are pleased to be working with the Tenzing Group and we are impressed with the knowledge and background the company has to help guide us through FDA classification understanding," said Dr. Scott Jenkins, CEO of m-Health Technologies Inc. "Having a specialized practice on the challenges of both mobile and healthcare, makes the Tenzing Group unique in this field."

The Tenzing Group announcement comes at a pivotal time in the industry as the House Subcommittee on Communications and Technology held recent hearings on possible FDA regulation of MMA s and consideration that they could be classified as medical devices.


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