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Reg Information/Data for Devices, very important going forward!

Every day device manufacturers face challenges, especially if they have products in multiple countries. This can be …
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Integration & Reconciliation IRT Guidelines

IRT’s main function lies in Supplies Distribution throughout the study and acts as a Medication Assigning Tool durin…
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Technology Towards an Efficient Monitoring of Clinical Trials

Clinical Study and Technology are two such genres that are progressing at a rapid rate. The implementation of age ol…
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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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