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Bulk/Non-Uniquely Number Kits in a Study

If the Kits in a study are not identified with a unique number (Kit Number), then the study is intended to make use …
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Labeling Changes & Challenges to Comply with EU MDR

The introduction of European Medical Device Regulation (EUMDR 2017/745) gives great importance to the end user to as…
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We are Direct to Subject Ready

The advantages of the D to S is multi faced for Subjects, Sites, CROs and Sponsors. We recognized the increasing sig…
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Clinical Trial Supplies Accountability

To account all the Supplies of Clinical Trial is a Regulatory requirement. Traditionally people used to use paper ba…
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Digitize Instructions for Use (IFU) to Comply with EU MDR

The regulation brings digital enablement to the forefront, compelling electronic instructions for use. EU MDR is …
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