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eIFU Requirements Under the EU MDR and Regulation 2021/2226

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What is an eIFU?  In general, an eIFU is defined as a non-paper version of the instructions for use. Currently, the definition of an eIFU is not the same in each market. In the EU, acco…
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Cybersecurity of Medical Devices in USA

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Anyone submitting a premarket application or submission for a device classified as a “cyber device” must include information required by the FDA to ensure the device meets cybersecurity requiremen…
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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 (…
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Authors hate this and companies should respond

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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

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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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