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eIFU for Medical Devices: Country Specific Regulations and Benefits

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

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 (…
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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…
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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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Regulatory Impact Assessment; How are you handling this currently?

Regulatory Impact Assessment (RIA) need not be fully integrated into the regulatory policy processes from the beginning. Companies can start by undertaking RIA for certain key regulations which are…