The European Union has announced that it will temporarily allow remote audits of medical devices and in vitro diagnostics under the new regulations (MDR IVDR), set to go into effect on May 2021 and 2022 respectively. In a document published Monday, the European Commission agreed with industry and notified bodies that the ongoing COVID-19 pandemic […]
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How major medtech companies are responding to the looming EU MDR
Medtech companies that sell products in the European Union have a major deadline looming — one that’s already been put off once. The EU Medical Device Regulation (MDR) will replace the current EU Medical Device Directive (MDD) on May 26, 2021. Companies whose products are approved for sale in Europe must decide if they want […]
Just one third of CEOs believe their organization has the resilience to succeed
A new report released November 30, 2015 by The Economist Intelligence Unit (EIU) on behalf of BSI identifies a worrying gap in the capability of firms to maintain long-term growth. The global study of business leaders[1] reveals that just one third (29%) trust that their firms have fully embedded resilience practices, and less than half […]