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How to simplify Project Management in your enterprise

Posted by Aaron Norman on Jun 3, 2014 7:30:00 AM

I’ve been working with Project Managers from different industries and over the last few years and I have seen their pressure increase as managing projects seems to get more complex every year.

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Topics: Content Server, Project Management, PPM, program management, portfolio management, livelink, opentext

What does FDA Section 522 mean for Medical Device Companies?

Posted by Katherine Austin on Jan 21, 2013 7:00:00 AM

“Section 522”: FDA Can Order Extra Studies from Medical-Device Companies in Special Cases 

Medical devices can cause adverse effects that weren’t anticipated either by the manufacturers or by regulatory agencies. High-profile cases have included metal-on-metal hip replacements and transvaginal surgical mesh. According to the Government Accountability Office, there were about 3,500 medical device recalls from 2005 to 2009. Many of these were ranked as “Class I” recalls—in other words, they involved a defect serious enough to create a "reasonable probability of adverse health consequences or death."

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Topics: ELN, Electronic Lab Notebook, Quality Management System, Regulatory, QMS, FDA Regulations, Content Server, eNovator, Medical Devices, In Vitro Diagnostics, FDA, opentext, CE Mark

Top 10 Reasons Diagnostics Developers Should Use Electronic Lab Notebooks

Posted by Katherine Austin on Nov 27, 2012 2:55:00 PM

The Top Ten Reasons to Make the Switch to Electronic Lab Notebooks (Part I)

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Topics: ELN, R&D, Research, Diagnostics, Medical Devices, opentext

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