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Bulk/Non-Uniquely Number Kits in a Study

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If the Kits in a study are not identified with a unique number (Kit Number), then the study is intended to make use of the advantages of Bulk/Non Uniquely Numbered Kits. This concept of Kits ca…
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Labeling Changes & Challenges to Comply with EU MDR

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The introduction of European Medical Device Regulation (EUMDR 2017/745) gives great importance to the end user to assist with the safe and proper use of a medical device(s). The EU MDR and other U…
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We are Direct to Subject Ready

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The advantages of the D to S is multi faced for Subjects, Sites, CROs and Sponsors. We recognized the increasing significance of D to S which inspired us the build this features into our system. O…
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Clinical Trial Supplies Accountability

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To account all the Supplies of Clinical Trial is a Regulatory requirement. Traditionally people used to use paper based or Excel based tracking of the Supplies. This is tedious, time consuming and…
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Digitize Instructions for Use (IFU) to Comply with EU MDR

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The regulation brings digital enablement to the forefront, compelling electronic instructions for use. EU MDR is turning digitization on its head. This new regulation, which goes into effect Ma…
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