IQCP - Westgard QC - Blog - Page 2 - Results from #20

Tools, Technologies and Training for Healthcare Laboratories

A solution to IVDR over-regulation?

 The fallout of the IDVR continues. An interesting quote from a recent paper: "Although the EC aimed at bringing safe and effective medical tests to the EU-market, ~9,000 tests out of ~40,000 tests got lost in transition." Nearly a quarter of tests suddenly became unacceptable? That places IVDR at just above 2.2 Sigma. The proposed soluti...

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