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Unlocking the Future of Regulatory Affairs: The Role of Automation and Artificial Intelligence

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In today’s fast-paced, highly regulated industries, companies are under constant pressure to meet strict compliance standards. For businesses operating in sectors like pharmaceuticals, medical dev…
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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…
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How Automated Document Management Transforms Regulatory Submissions

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In today’s fast-paced regulatory landscape, staying compliant while managing vast amounts of documentation can feel overwhelming. Automated document management is emerging as the game-changer for …
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SaMD – USA and EU Approach Differences

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As per the FDA, the term Software as Medical Device (SaMD) is defined as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware…
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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…
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