Clinical Trials: Managing Labeling Approvals with Multi-Language and Multi-Region Regulations

The clinical trial market is not only global, today it touches more markets than ever before. Increasingly, a key component of this is the need to comply with variable local language labeling requirements, not least in the safe distribution of medicines for clinical trials. With the global map for clinical studies now extensive, information to support the safe and effectual use of trial medicines must be coherent and understandable to the patients receiving them.

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FDA Regulations for Inspection

Ignoring the warning signs of non-compliance is no longer an option

Data shows that more than half of all FDA recalls of medical devices since Q1 2014 have been caused by packaging and/or labeling error. One of the most high profile recent examples was the Class I recall of a Peripheral Infusion System, where major mislabeling risked the incorrect use of the product by physicians and raised the potential for serious patient injury or death.

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Survey results show how label inspection is undertaken within the industry

At PRISYM ID we’re keen to understand how medical device, pharmaceutical and clinical trial companies check the labels they print for quality.

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UDI: An inconvenience or a chance for change?

It’s nearly three years since the original publication of UDI and the industry is well on track to achieving compliance. Indeed, April 2016 saw GUDID Labeler Accounts rise from 240 in October 2014 to 1275* only a year and a half later.

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