Increased recalls, pricing pressures and a changing regulatory environment, have many Life Science firms wondering how to prepare for the future. We’ve seen change in the horizon after the FDA...
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The next 12 months will likely change the regulatory and compliance landscape for Life Sciences companies. An administration change coupled with a case for quality initiative will drive a new...
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Mergers and Acquisitions are a major part of strategic play for medtech companies. A consolidation trend has been occurring in the industry the past several years and will likely continue...
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As a result of a system that is in need of revamping, the FDA's Center for Devices and Radiological Health announced its 2016 - 2017 Strategic Priorities that included a...
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As a result of a system that is in need of revamping, the FDA's Center for Devices and Radiological Health announced its 2016 - 2017 Strategic Priorities that included a...
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Let's take a look at the chain of events that have and will alter the Medical Device Industry indefinitely. Medical Device recalls and incidents have escalated over the past decade....
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When a company voluntarily or involuntarily recalls a product, the opportunity cost can be great. A survey released by EMERGO in January 2015 showed that, of three main challenges facing...
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The global regulatory landscape is changing rapidly and becoming increasingly competitive for medical device, pharmaceutical and biotechnology companies. The pressures of the market, technology advances, globalization, and the rapidly shifting...
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There is a diverse array of explanations for the rise in medical device recalls in the past decade. A few of these reasons include the increasing complexity of these devices,...
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The amount of defective medical device recalls almost doubled from 2003 to 2012, says a 2014 report from the Food and Drug Administration (a nearly 100% increase during those years)....
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