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

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Every day device manufacturers face challenges, especially if they have products in multiple countries. This can be from business needs or local demands or regulatory compliance that needs to be m…
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Integration & Reconciliation IRT Guidelines

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IRT’s main function lies in Supplies Distribution throughout the study and acts as a Medication Assigning Tool during Randomization/Enrollment. IRT is designed in such a way that it captures only …
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Technology Towards an Efficient Monitoring of Clinical Trials

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Clinical Study and Technology are two such genres that are progressing at a rapid rate. The implementation of age old practices does not suffice in any of the scenarios. Clinical trials are common…
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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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