The training will focus on developing Software as a Medical Device (SaMD). However, since the IEC 62304 standard is essential, the course will also be valuable for developers of Software in a Medical Device (SiMD).
We will begin with the IEC 82304-1 standard and go through each step of the software development process, with practical examples and forms to aid understanding.
Although SaMD development might seem no more complex than embedded software development (SiMD), it often presents unique challenges.
The aim of this training is to provide a clear, practical overview of the SaMD development and documentation process, supported by real-life implementation examples.
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