September 2013

For Medical Device Companies

How to Prepare Your DHF for the FDA

by: Robert Packard,

FDA inspections strike fear into most companies, but most of the fear is due to a lack of knowledge about what to expect from the FDA. Therefore, the person responsible for the design control process at your company should read two important documents—in addition to this article: The Quality System Regulation Preamble and The Quality System Inspection Technique Manual. Do you know what these documents contain?

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Future Growth Sectors May be Different Than You Think

by: Michelle Bonn, Expedient Trade LLC

The medical industry is one of the most stable industries with respect to growth. However, we are seeing interesting global trends that will impact the sustainability of medical device manufacturers and suppliers across the United States. Michelle Bonn reviews the trends that will impact the medical device market.

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by: Victor Gill, MasterControl Inc.

What exactly is Cloud? Or is it The Cloud? Vic Gill provides an overview of what “cloud” is and what it can do for your business.

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Coming Soon:

MasterControl’s Walt Murray is back to explain how to implement a master validation plan. Walt is an experienced consultant with years of practice in this area.

Vivian Bringslimark is passionate about training. She’ll share that passion in “SOP Training is Now Online but Are We Any More Compliant?”

MasterControl’s Cloud expert Victor Gill is back with a second installment on “MasterControl.Cloud.” In his first article, he explained in layman’s terms what the Cloud is. In the next issue, he’ll talk about how working in the Cloud can make you more efficient in your work.

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