While not an exhaustive presentation of all relevant laws/procedures, we have summarized the general concepts to introduce you to the chinese regulatory compliance rationale.

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.

Looking for the basics of #VDR? Check out this summary of IVDR  and contact us to discuss your tailored needs.

In this paper we will discuss the challenges a CER author will have to overcome while building up a SoTA section, as well as resources and practical solutions/best practices to facilitate its