June 2013

For Medical Device Companies

Disaster Recovery and Validation

by: Louis Rutledge, Manager of Services Development / Validation Services

Disaster! Today’s business world shudders at the word. With the current random occurrences of hurricanes, super storms, earthquakes, blizzards, fires, flooding and sustained power outages, it is a wonder how companies can recover to survive all of the natural or modern threats to their daily business operations and collection of business data. Today’s business world is dependent on the data created and stored for many aspects of daily operations: financial data; product specifications; designs; testing records; and quality management systems (QMS) data are only a few examples. How can you protect your precious data in the face of all these threats?

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Pharma Must Provide Convincing Evidence of Drug Value

by: Michelle Bonn, President, Expedient Trade LLC

Since the medical device and drug industries have transitioned into global market players, the concept of "virtual manufacturing" has grown in popularity and necessity.

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FDA Data Shows Increase in Warning Letters to Medical Device

by: Stewart Eisenhart, Emergo Group

Emergo Group reports on the steady increase in Form 483 observations and warning letter citations with higher rates of FDA Quality System Regulations since 2008.

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5 Superhero Technologies that Medtech is Bringing to Life Today

by: Chris Wiltz, Associate Editor, MD+DI

The weather's getting warmer. Summer movie season is just around the corner. And that means one thing: Superheroes! We all like to imagine ourselves being able to do incredible things. But before you get too lost in the science fiction, let's take a look at some superhero technologies that medical science is bringing closer to us each day.

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