Discussion of GSPRs in the conclusions section of a CER

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When writing your section of conclusions and discussing General Safety and Performance Requirements (GSPRs), make sure you adjust it to the profile of each medical device.

Apart from Requirements 1-9, a separate overview of ALL applicable Requirements should be included in your CER.
Contact Evnia today for tailored clinical evaluation services that will adjust our generic CER templates to a document that will address your portfolio’s specific needs

Download the document here.

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