A medical device design process that fosters innovation, complies with regulatory standards and increases trust with its users relies on a number of key ingredients. Learn about the four tactics that will help you boost innovation in a regulated industry like medical devices.
Read MoreMedical 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.
Read MoreLast 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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