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Nov202018

Shelf Life Studies

Blogs, CE MarkBy adminqara November 20, 2018

Every medical device is labeled with an expiry date that is supported by shelf-life data. Shelf life is the time period during which a medical device remains suitable for its intended use. An expiration date mentioned over the labels is the termination of shelf life, after which a percentage of the medical devices, may no longer function as their intended use.

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Jul212016

FDA Calls on those issuing Misleading “FDA Registration Certificates”

510K, BlogsBy adminqara July 21, 2016

US FDA does not issue any type of Certificates to any organization stating registration or Listing successful.

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Jun92016

UDI DI Number in Medical Devices

Blogs, CE MarkBy adminqara June 9, 2016

The UDI is a series of numeric or alphanumeric characters created through a globally accepted device identification and coding standard. It allows identification of a medical device on the market. The UDI comprises of UDI-DI and UDI-PI.

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