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Process Measurable Objectives

Posted 27th December 2017 at 10:45 AM by sherley13
Updated 27th December 2017 at 10:56 AM by sherley13

Auditor Questions:

Organization specifies its objectives in a rather general manner. It also specifies its processes. It is not clear how the general objectives of the organization are mirrored to the processes and how the measurable...
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Resterilization - Disposable devices

Posted 7th August 2014 at 01:30 PM by sherley13
Updated 7th August 2014 at 01:49 PM by sherley13

Dear All,

The Disposable devices packed in Tyvek pouch and sterilized by Ethylene Oxide and this device is sterilized by original manufacturer. Can distributor do Re-sterilization of this product again?.

(Note : The product...
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Class I Device - Reusable Instruments labeling requirements

Posted 30th January 2014 at 12:13 PM by sherley13

Reusable Surgical Instruments are Classified as Class I device according to MDD 93/42/EEC, the device “Forceps” selling in EU country what is the labeling requirements for the distributor. The following are my question.

1.Does Class...
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Disposable Loop Electrode - GMDN/or UMDNS code?

Posted 21st January 2014 at 04:31 PM by sherley13

Please let us know the Disposable Loop Electrode GMDN/or UMDNS code??? Pl help
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