Due to the overwhelming demand for updates to ISO 13485 which regulates medical device compliance; we expect to see some important changes by quarter 1 of 2016.
The biggest revision expected is the compliance with international regulations; ensuring consumers that these devices have been tested and meet all safety requirements across the globe is something that hasn’t been addressed until this upcoming revision.
Along with meeting international compliance also addressed was the need to have archived technical information for every medical device. This includes product specifications, instructions for use, labeling and clinical data. The expectation is to have full detail on a product for reference to an issue, recall or replacement of a specific part.
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