In a recent quarterly 2015 report, the US Food and Drug Administration (FDA). [...] Read More

Properly managing sensitive information to maintain privacy and security has. [...] Read More

The CAPA process from the side of regulatory compliance of both U.S. FDA. [...] Read More

In 2015, the US Food and Drug Administration (USFDA) issued Warning Letters to. [...] Read More

Excluding the United States, European recommendations for medical device. [...] Read More

In February of 2014 the Food and Drug Administration (FDA) published the final. [...] Read More

Regulatory bodies like the FDA enact initiatives on a routine basis. While. [...] Read More

As a medical device manufacturer, how do you identify your compliance. [...] Read More

You've received one of the dreaded FDA Warning Letters. The last thing you want. [...] Read More

The FDA can be slow to change its ways, but its guidelines aren't immutable. As. [...] Read More