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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Medical device regulations require information to be recorded as you develop; this includes how the design was created, why design decisions were made, and what risks were considered in the process. Here is a basic outline to get you started.
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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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Maren Nelson, a PMP-certified, medical device consultant for Product Creation Studio talks to startups on how they can establish informal documentation from the start, examples of accepted criteria and three guiding principles of any quality management system.
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