lifeIMAGE Completes First Inspection by the Food & Drug Administration

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The company’s Quality Management System examined for compliance with medical device regulations.

lifeIMAGE

"The FDA inspection was a great opportunity to validate how well we live up to our own standards," said Amy Vreeland, lifeIMAGE Co-Founder and Sr. VP of Product Management & Marketing

lifeIMAGE announced today that the United States Food and Drug Administration (FDA) recently completed its first inspection of the company. An FDA inspector visited its headquarters for four days in August and conducted a routine examination of the company’s Quality Management System (QMS). The lifeIMAGE leadership team is pleased with the outcome of the inspection.

The inspection was prompted after lifeIMAGE proactively registered itself with the FDA as a medical device manufacturer in December 2011. This was done to ensure compliance with the agency’s Medical Device Data Systems (MDDS) Rule, which took effect in April 2012. The new MDDS Rule categorizes products such as those offered by lifeIMAGE as Class I medical device and as such the organization is required to comply with the Quality System Regulation. lifeIMAGE took appropriate action to construct a comprehensive QMS, which was examined by the FDA in August.

“Everyone at lifeIMAGE is very satisfied with the outcome of the recent FDA inspection,” said Brian Scogland, Regulatory Affairs Manager for lifeIMAGE. “Our QMS withstood a particularly rigorous examination. We have built a strong foundation on which we can continue to deliver quality products.”

According to the FDA, “MDDS are hardware or software products that transfer, store, convert formats, and display medical device data. An MDDS does not modify the data or modify the display of the data, and it does not by itself control the functions or parameters of any other medical device. The quality and continued reliable performance of MDDS are essential for the safety and effectiveness of health care delivery. Inadequate quality and design, unreliable performance, or incorrect functioning of MDDS can have a critical impact on public health.”

“lifeIMAGE has always been committed to the quality of the products we bring to market,” said Amy J. Vreeland, Co-Founder and Senior Vice President of Product Management & Marketing at lifeIMAGE. “The FDA inspection was a great opportunity to validate how well we live up to our own standards. We will continue to have a steadfast focus on our QMS - it is a well designed guideline to ensure the strength of our products, the satisfaction of our customers and continual improvement throughout our organization.”

About lifeIMAGE
lifeIMAGE provides a broad set of solutions for universal e-sharing of diagnostic imaging information. These products connect hospitals, radiology groups and physicians to their patients everywhere. lifeIMAGE makes it possible to securely deliver or receive patient imaging information wherever needed from wherever the information originates.

The goal of the lifeIMAGE platform is to help avoid duplicate exams and eliminate unnecessary patient exposure to excessive radiation. In an era of concerns about rising healthcare costs, lifeIMAGE is investing in a platform that helps advance patient care, while reducing $10 billion to $15 billion of unnecessary costs. lifeIMAGE was named one of the most innovative technologies by The Wall Street Journal as part of its international 2010 Technology Innovation Awards. lifeIMAGE solutions are deployed at nation’s leading healthcare institutions and academic medical centers.

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Jackie Walsh
lifeIMAGE
(617) 990-2262
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