Sticking plasters on chronic wounds: time to strengthen EN ISO 13485:2012
This article was originally published in Clinica
Executive Summary
As medical technology advances, regulations become more stringent, and standards must adapt to reflect the regulatory advances. But one of the most critical to the medtech industry is failing to keep up with regulatory progress in the EU and is becoming outdated. In this article, independent medtech consultant Gabriel Adusei argues why the sticking plaster approach to the EU quality management system standard is not enough
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