January 13, 2021

[FEATURED] COVID-19 And FDA: Official Tells How Pandemic Has Affected Agency’s Regulatory Work

US FDA device center associate director Erin Keith explained how the agency adapted – and continues to adapt – to the COVID-19 pandemic when it comes to medical device and diagnostic regulation.

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January 6, 2021

[FEATURED] EU Industry Is Largely Ready For Brexit: This Is Why

Brexit will be painful economically for medtech and create more work for companies in the remaining 27 EU countries who want to sell to Great Britain and Northern Ireland. But much has been done to mitigate the degree of pain once expected.

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October 15, 2019

[FEATURED] Cost Of Certification Under IVDR Is Going To Be Huge As Manufacturers Battle Hurdles

There has been no recent impact assessment as to how business will be affected by the text of the IVD Regulation that was finally adopted. Consultant Robyn Meurant explains how industry will be paying a high price, and why many IVD companies could go under.

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