Regulations
SaMD – USA and EU Approach Differences
As per the FDA, the term Software as Medical Device (SaMD) is defined as “software intended to be used for one or mo…
eIFU Requirements Under the EU MDR and Regulation 2021/2226
What is an eIFU?
In general, an eIFU is defined as a non-paper version of the instructions for use….
eIFU for Medical Devices: Country Specific Regulations an…
There are several benefits of using electronic Instructions for Use (eIFU) labeling for medical devices, including…
Regulatory Impact Assessment; How are you handling this c…
Regulatory Impact Assessment (RIA) need not be fully integrated into the regulatory policy processes from the beginn…
FDA: Software Assurance guidance for Production and Quali…
This draft guidance is intended to:
Computer Software Assurance is a risk-based approach to establish confidence…
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