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Regulations

eIFU for Medical Devices: Country Specific Regulations and Benefits

There are several benefits of using electronic…

SaMD – USA and EU Approach Differences

As per the FDA, the term Software as Medical D…

eIFU Requirements Under the EU MDR and Regulation 2021/2226

What is an eIFU?  In general, an eIFU …

Cybersecurity of Medical Devices in USA

Anyone submitting a premarket application or s…

Regulatory Impact Assessment; How are you handling this currently?

Regulatory Impact Assessment (RIA) need not be…
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