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Category: Medical Device Industry

Jan
22

Canada’s Legalization of Cannabis Puts New Demands On Manufacturers

In October, Canada became the first major economy, and second country, to legalize cannabis. While this policy shift will undoubtedly have consequences for consumers, law enforcement officials and others, it also presents new challenges for the cannabis manufacturers seeking to profit from what could be a $5 billion industry. As manufacturers compete for a limited number of licenses and confront an increased level of scrutiny, recall preparedness and a thorough understanding of regulatory requirements will be crucial to success.

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Aug
29

The FYI on UDI

It has been five years since the Food and Drug Administration (FDA) released a final rule establishing a unique device identification (UDI) system for the medical device industry. The benefits are numerous and include more accurate reporting of adverse events, a reduction in medical errors, and more effective management of medical device recalls.

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Nov
02

Budgeting for a Pharmaceutical or Medical Device Recall

It’s budgeting season, and most leaders are hoping and planning for a banner year. New product developments. Innovative strategies. Expanded market share. Everyone hopes they will avoid any sort of crisis in the coming year, and as a result, few plan for one. But one of the most disruptive crises medical device and pharmaceutical companies will face is also among the most likely – product recalls. Consider this: Through Q3 2017, 144 companies experienced more than one pharmaceutical or medical device recall.

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Aug
29

A Bitter Pill: Recalled Pharmaceutical Units Increase 444 Percent in Q2

By ExpertSolutions Tags: Recall Index,

Pharmaceutical recall activity saw a disturbing rise not only in the volume of products recalled last quarter, but also in the severity of risk to consumers, according to the Q2 2017 Recall Index. Pharmaceutical recalls increased 6 percent over the previous quarter to 86. More jarring, the volume of recalled drug units circulating in homes and store shelves climbed 444 percent over the previous quarter, making it the most active quarter since Q4 2014.

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Aug
11

Device Disconnect: UDI and EHR Challenges in Medical Device Recalls

Medical device manufacturers have worked to meet the Food and Drug Administration’s (FDA’s) stricter regulations for Unique Device Identification (UDIs) every year since September 2014. Now humans and computers can access vital product information like never before, all from the special barcodes on the latest medical devices.

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