Software as a medical product has become a widespread approach, both as part of an embedded device and as a standalone application. This article outlines how to address risk in your design process through software best practices IEC 62304.
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Last year, substantial changes to Medical Device Regulations (MDR) were approved by the European Council to take full effect in mid 2020. If you are planning to market a medical device there, it’s important to understand the new changes.
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