Medical image sharing firm LifeImage announced that the U.S. Food and Drug Administration (FDA) completed its first inspection of the company's headquarters and conducted an examination of the company's quality management system.
The inspection was prompted after LifeImage registered itself with the FDA as a medical device manufacturer in December 2011 in order to ensure compliance with the agency's Medical Device Data Systems rule, which took effect in April 2012.
The new rule categorizes products such as those offered by LifeImage as class I medical devices. LifeImage constructed a comprehensive quality management system, which was examined by the FDA in August, the company said.
