Industry Insights

: 04 September

Regulation of medical devices in China

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.

: 31 August

Discussion of GSPRs in the conclusions section of a CER

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.

: 28 August

The basics of the new In-Vitro Diagnostics Medical Devices Regulation (IVDR)

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

: 21 August

White Paper: State of the Art in the context of the new Medical Device Regulations

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 preparation.

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: 17 August

Clinical Data sources for Clinical Evaluation Reports

A clinical evaluation report (CER) retrieves and appraises clinical data from various sources in order to provide evidence that a medical device is conforming with GSPRS. We have summed up the commonest sources for you.