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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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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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