Medical Device Industry
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FDA Takes GUDID Offline: Security breach? Or Proactive Measures?

FDA Takes GUDID Offline: Security breach? Or Proactive Measures? | Medical Device Industry | Scoop.it

FDA detected a “security vulnerability” earlier this month that spooked it enough to take the highly touted Global Unique Device Identification Database (GUDID) offline until it was able to affix, electronically, a suitable security patch. The announcement came via a guidance dated August 14.

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Audit Management: the Perennial EQMS Straggler

Audit Management: the Perennial EQMS Straggler | Medical Device Industry | Scoop.it

AssurX has been in the business of configuring and implementing Enterprise Quality Management Solutions for two decades, and over that time, it has been a consistent finding that audit management tends to reside near the end the typical EQMS process implementation schedule.

 

Why does the management of audits always seem to take a back seat to other processes like CAPA, document control, and complaints, when it comes to implementing an enterprise quality management system?

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FDA’s UDI Initiative Continues to Roll Forward

FDA’s UDI Initiative Continues to Roll Forward | Medical Device Industry | Scoop.it

With the close of the 7th Annual UDI Conference in Baltimore late last month, FDA took another big step forward in providing an electronic library of medical device information. During the conference, FDA shared a number of milestones completed in the last eight months since the previous conference.

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U.S. tax on medical devices a huge burden

U.S. tax on medical devices a huge burden | Medical Device Industry | Scoop.it
By Stephen J. Ubl The U.S. House of Representatives recently voted to repeal a major new tax established by the 2010 health care reform law — a $30 billion levy on medical device firms.
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Venture Capitalists Show Confidence in Medical Device Sector

Venture Capitalists Show Confidence in Medical Device Sector | Medical Device Industry | Scoop.it

investment in medical device and technology companies, while still lower than what therapeutics garnered, was up 37% in the first half of 2012, from $1.1 billion in 2011 to $1.5 billion in these most recent figures available.

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GAO Report Finds Steady Medical Device Profit Climb – Especially the Big Boys

GAO Report Finds Steady Medical Device Profit Climb – Especially the Big Boys | Medical Device Industry | Scoop.it

A new Government Accounting Office (GAO) report designed to shed light on what impact the medical device tax will have on the industry in the future might have done a better job of taking us under the industry’s financial hood today.

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Obama Veto Threat Looms Over Medical Device Tax Battle

Obama Veto Threat Looms Over Medical Device Tax Battle | Medical Device Industry | Scoop.it

With medical industry trade groups and many House and Senate members lined up on one side determined to repeal the medical device tax, the other side may have the final ace: a veto threat by President Obama.

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Will New User Fees Fuel More FDA Inspections?

Will New User Fees Fuel More FDA Inspections? | Medical Device Industry | Scoop.it

For FY 2016, FDA is requesting $4.9 billion to support our essential functions and priority needs, which is $425 million above the FY 2015 enacted level.  Of the total funding, $2.7 billion is budget authority and $2.2 billion is user fees.  The FY 2016 increase consists of $148 million in budget authority and $277 million in user fees.

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When Medical Devices Are Too Good | MDDI Medical Device and Diagnostic Industry News Products and Suppliers

Sprinter Oscar Pistorius, of South Africa, is set to become the first double amputee to run in the Olympics, but his path to the games has been rife with controversy.
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What the Heck’s Going On at the FDA?

What the Heck’s Going On at the FDA? | Medical Device Industry | Scoop.it

The Cold War may be over, but apparently spying is still a growth industry. The latest spy craft news comes from the seemingly staid Food and Drug Administration, which appears to have more George Smiley and John LeCarre types than we’d ever imagined.

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