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Basics of Unique Device Identification (UDI)

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What is UDI?  An UDI is a distinct numeric or alphanumeric code used to identify medical devices throughout healthcare supply chains. These codes are generated by product owners based on g…

eIFU for Medical Devices: Country Specific Regulations and Benefits

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There are several benefits of using electronic Instructions for Use (eIFU) labeling for medical devices, including: 1. Accessibility: eIFUs can be accessed from anywhere with an internet connec…

Technical Documentation – Future proof and save time/costs

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Technical Teams often produce a large percentage of their documents and Inefficiencies are introduced when teams create long and complex technical documents like GSPR, STED, regulatory documents (…

Authors hate this and companies should respond

Where do authors spend most time that they hate. Easy guess, it’s Formatting and reviews.  In spite of process documents, templates, rule books, qc checklists, authors still spend lot of t…

Site Wise Randomization benefits and managing with IRT

Clinical trials are essential for evidence-based medicine, providing critical insights into the efficacy and safety of new treatments. One crucial aspect of conducting clinical trials is the rando…

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